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A re-evaluation of the comedogenicity concept
Abstract
Comedogenicity is an important consideration in the development of topical medications, cosmetics, and skin care products. The concept of "acne cosmetica" was developed to link the use of certain ingredients to comedo formation. Animal models were originally used to determine the comedogenic potential of raw materials with the assumption that finished formulations containing these ingredients would also be comedogenic. Based on this assumption, dermatologists were presented with lists of substances to avoid in patients with the ability to develop comedones.
We sought to use a modification of the Mills and Kligman human assay for assessing comedogenic potential of finished cosmetic products.
Six individuals with prominent follicular orifices and the ability to form comedones on the upper aspect of the back were enrolled. Each person received patches to the upper aspect of the back saturated with 0.2 to 0.5 mL of the finished cosmetic study products 3 times weekly for 4 weeks. Cyanoacrylate biopsies were performed to determine the number of follicles and microcomedones per square inch.
Only a finite number of finished cosmetic products could be analyzed.
Finished products using comedogenic ingredients are not necessarily comedogenic.
... The comedogenic potential of dermatological products has been documented since 1972 by Kligman AM and Mills OH [1]. The comedogenic activity of the dermatological ingredients, for example, apricot kernel seed oil, cocoa butter, corn oil, isopropyl myristate, mineral oil, acetylated lanolin, octyl palmitate, sunflower oil, sodium lauryl sulfate, tocopherol etc. has been listed [1][2][3]. These results were conducted from testing of 100% concentration of the tested ingredients in animal models, namely rabbit ear assay. ...
... In the present study, the comedogenicity of the marketed dermatological products were assessed by using human model modified from the previous study [3,4]. All tested products contained d-Alpha tocopheryl acetate in an amount 5 IU/100 g of product, as a main active ingredient. ...
... Each enrolled subject was given pads containing the tested products to apply to the upper aspect of the back. The positive control was the pad containing octyl palmitate which has been reported as a comedogenic material [3,4]. The negative control was a pad without any material. ...
A double-blind randomized controlled trial was used to assess the comedogenic potential of the dermatological products containing d-Alpha tocopheryl acetate. A total of 15 healthy males (20–45 years old) with prominent follicular orifices and the ability to form comedones on the upper aspect of the back were enrolled. Each participant was given pads containing 4 test products. The positive control arm received a pad containing octyl palmitate which is a reported comedogenic material. The negative control arm received a pad without any test material. Participants were randomized to apply either the positive, negative or the active test cream to the application area for 4 weeks. Comedones were identified using epidermal biopsy under a stereomicroscope. The average number of microcomedone before exposure (baseline) with octyl palmitate was 6.1 ± 0.6 (mean ± SEM), and changed to 27.3 ± 4.7 which was more than 50% increase in comedone formation in every subject with the average change from base line was 365.4 ± 87.6%. In the negative control arm the average number of microcomedone at baseline was 6.4 ± 1.1 and at 4 week-application was 3.4 ± 0.6 (−43.0 ± 9.5% increased). All tested products produced less than a 50% increase in the number of microcomedones. Analyzed data from 12 subjects indicated non-comedogenic potential of the tested products containing-alpha tocopheryl acetate and other ingredients including lanolin, kernel oil and avocado oil and sunflower oil, etc. The octyl palmitate produced more than 50% increase in comedone formation in every analyzed subject.
... However, the degree in comedogenicity varied depending on other co-excipients and also the percentage of comedogenic compound. Therefore, the amount of excipient in the formulation and its interaction with co-ingredients are important considerations when designing vehicles for comedone prone individuals [10]. ...
... The azelaic acid is the only cream out of the ten acne therapies (Finevin™, Bayer, Germany). Although the cream consists of some excipients with relatively low comedogenic properties (propylene glycol, glycerine), it contains several ingredients that have been reported to have medium to high comedogenic properties [9,10]. However, studies have shown that long term use of azelaic acid results in a decrease in 'greasiness' of the skin [13]. ...
... Nanoemulsions have been reported to efficiently stabilize antioxidants. Medium chain tryglycerides nanoemulsions have been proposed for the formulation of coenzyme Q 10 . The formulation remained stable for 12 months and showed a good protection of the drug, with more than 90% of the drug still present even at a storage temperature of 40˚C. ...
The skin has evolved to resist the penetration of foreign substances and particles. Topical therapeutic and cosmeceutical delivery is a growing field founded on selectively overcoming this barrier. Both the biology of the skin and the nature of the formulation/active ingredient must be aligned for efficient transcutaneous delivery. This review discusses the biological changes in the skin barrier that occur with common dermatological conditions. This context is the foundation for the discussion of formulation strategies to improve penetration profiles of common active ingredients in dermatology. Finally, we compare and contrast those approaches to recent advances described in the research literature with an eye toward the future of topical formulation design.
... The comedogenic effect relates to the use of cosmetic formulations containing certain ingredients capable of producing comedones [122]. For a comedogenic effect, it has been generally accepted that a compound must penetrate into the follicle and produce hyperkeratosis [123]. ...
... Ideally, only non-comedogenic components should be used to claim that a formulation is non-comedogenic, but considering that the effect is influenced by the concentration of a compound, the duration and the frequency of exposure, the properties of the final formulation may actually vary. In a comparative study, formulations containing one or more comedogenic compounds were considered non-comedogenic when their concentration decreased [122]. This provides one explanation for why water-continuous formulations are generally considered less comedogenic [123]. ...
... Additionally, the endpoint evaluated and model used may provide different results that further complicate formulation evaluation. Different results have been reported for compounds tested on the rabbit ear or human models and on assays employing macroscopic or histological evaluation or follicles and comedones [122]. ...
Microemulsions are fluid and isotropic formulations that have been widely studied as delivery systems for a variety of routes, including the skin. In spite of what the name suggests, microemulsions are nanocarriers, and their use as topical delivery systems derives from their multiple advantages compared to other dermatological formulations, such as ease of preparation, thermodynamic stability and penetration-enhancing properties. Composition, charge and internal structure have been reported as determinant factors for the modulation of drug release and cutaneous and transdermal transport. This manuscript aims at reviewing how these and other characteristics affect delivery and make microemulsions appealing for topical and transdermal administration, as well as how they can be modulated during the formulation design to improve the potential and efficacy of the final system.
... We have come a long way from the introduction of the term 'Acne Cosmetica' by Kligman and Otto, and the use of the conventional ingredient-based rabbit ear comedogenicity testing and grading model. Today non-invasive human follicular biopsy with cyanoacrylate glue and the newer 'in use-real world' human testing of finished products, have increased the practical relevance and interpretation of comedogenic potential of skin-care products [5][6][7][8]. ...
Editorial for World Acne Awareness Month June 2020 in Archives of Clinical and Experimental Dermatology.
... Bahan-bahan kimia yang ada dalam kosmetik dapat langsung menyebabkan acne ringan terutama komedo tertutup dengan lesi papulo pustul di daerah wajah.Terjadinya acneakibat penggunaan kosmetik sering dikenal dengan istilah"AcneCosmetics" (Draelos, 2006). Acne lebih banyak ditemukan pada daerah dagu dan pipi,dibandingkan dengan daerah dahi. ...
Acne vulgaris is one of problem skin disease for adolescents and young adults. Acne vulgaris(AV) is a chronic inflammation of pilosebasea follicles with multifactorial causes and has clinicalmanifestations such as blackheads papules, pustules, nodules and cysts. Risk factor of acne vulgaris isobesity. Obesity usually happens along with peripheral hyperandrogen and can increase sebumproduction. Facial care consists of cleaning, moisturizer and sun protector and analyzed relation withseverity of acne vulgaris. The purpose of this study was to determine the relationship of gender, bodymass index and facial care to severity of acne vulgaris. This study was an observational analytic withcross sectional method and the sampling was chosen by purposive sampling. The minimum sample sizewas 59 subjects. Data from this study were obtained from measurement of body mass index anddiagnostic photos in acne prone subjects. The result of statistical tests showed that there was relationshipbetween sex with the severity of acne vulgaris with (p = 0.014) and severity of acne vulgaris having anopportunity 6 times greater in males than females. Body mass index and facial care have no relation tothe severity of acne vulgaris.
... Auf Konservierungsstoffe und andere Komponenten, deren Sensibilisierungspotenzial als vergleichsweise hoch eingestuft wird, sollte insbesondere dann verzichtet werden, wenn Alternativen mit geringerem Sensibilisierungs- potenzial verfügbar sind.Da zur Anwendung im Gesicht vorgesehene Dermokosmetika gegen Hautalterung nicht sel- ten auch von jüngeren Menschen angewendet werden, sollte sichergestellt sein, dass sie kein komedogenes Potenzial besitzen. Dazu sollte möglichst auf Inhaltsstoffe verzichtet werden, die sich in entsprechenden Prüfmodellen[123,124]nachweislich als komedogen erwiesen haben.Dermokosmetika gegen Hautalterung, die hohe Anteile an Antioxidantien mit starkem Redukti- onspotenzial enthalten, könnten im ungünstigs- ten Fall in der Haut unerwünschte prooxidative Effekte bewirken (siehe Kapitel 6.2). Um dieses Risiko zu minimieren, sollten die Antioxidantien sorgfältig auch nach toxikologischen Kriterien ausgewählt und nur in wirklich bedarfsgerech- ten Konzentrationen eingesetzt werden. ...
Falten reduzieren, die Haut straff halten und einen frischen Teint herbeizaubern — diese Versprechungen machen Cosmeceuticals. Sie enthalten meist effektivere Inhaltsstoffe als herkömmliche Kosmetika.
... Furthermore, there is also so called cosmetic acne, which is a concept introduced by Kligman and Mills (1972), that refers to the formation of acne lesions resultant from the use of cosmetic products containing certain comedogenic ingredients that can interfere with hydrolipidic balance, aggravate the follicle obstruction and can form acneic lesions (Humbert, 2002;Draelos and Dinardo, 2006). ...
Excessively oily skin leads to clinical signs that cause discomfort to patients, such as excessive shine, enlarged pores, acne, and an imbalance of the hydrolipidic layer. In this context, a constant demand for the research and development of products that prevent these features, has been noted in the field of cosmetics and dermatology. Thus, the objective of this study is to evaluate the cutaneous characteristics of oily skin due an excessive production of sebum through biophysical and skin imaging techniques. 19 participants with different skin types were selected and the following parameters were evaluated: pore count, determination of the number of sebaceous glands and amount of sebum in infundibulum, determination of cutaneous microrelief, count of comedones, evaluation of epidermis thickness, characterization of the cellular, and comedone size and its characteristics. These evaluations were done through biophysical and skin imaging techniques. The obtained results showed that different regions of the face presented different characteristics related to oiliness, quantity, and the appearance of pores and comedones. The malar region had a lower epidermis thickness and a larger number of large pores. Moreover, in this region excessive sebum production, which can be related to pores, not comedones, was noted. The nose region presented higher sebum content in the infundibulum and lower active sebaceous glands, showing a higher activity of sebaceous production in this region. The chin region presented a positive correlation between the sebum content, roughness parameter and the number of pores and comedones. As different skin properties are related and influence the appearance of undesirable clinical signs, we identified the need for a multifactorial approach for the effective treatment of oily skin. The rational development of multifunctional cosmetic products that promote the control of oily skin, that regulate the keratinization process, improve the microrelief and leads to a better epidermis and dermis structure, will not only improve oily skin conditions but will also allow for the reduction or disappearance of clinical signs that result from excessive oiliness, all of which causes concern and results in a relentless search for cosmetic and dermatological products that address the unaesthetic nature of these conditions.
... There are currently two methods to evaluate comedogenecity. One is the inexpensive human model developed by Mills and Kligman and modified by others (8). The second is the more costly human clinical trial, which is the gold standard for comedogenesis and to which the human model is compared. ...
There are currently two methods to evaluate comedogenecity. One is the inexpensive human model developed by Mills and Kligman and modified by others. The second is the more costly human clinical trial, which is the gold standard for comedogenesis and to which the human model is compared. The qualification of each method to support the comedogenecity claim is evaluated and contrasted.
... Cependant, des tests réalisés par Mills et Kligman (1982) sur le dos de jeunes hommes ont conduit à des résultats différents. Plus récemment, Draelos et DiNardo (2006) ont testé des produits cosmétiques contenant un ou plusieurs produits comédogènes. Leurs résultats montrent que les produits cosmétiques finis utilisant des ingrédients reconnus comédogènes ne sont pas nécessairement comédogènes. ...
L’acné représente l’un des motifs de consultation les plus fréquents en dermatologie, notamment chezl’adolescent et le jeune adulte. Cette pathologie est complexe et multiparamétrique et, à ce titre, cemémoire présente les mécanismes impliqués dans la pathogenèse de l’acné, les facteurs de risquesassociés et les effets des médicaments utilisés dans le traitement de l’acné en France.La pathogénie de l’acné fait intervenir plusieurs groupes de mécanismes que sont une hyperséborrhéeavec une modification de la composition du sébum, une hyperkératinisation des follicules pilosébacés,une amplification de la colonisation de ces follicules par la bactérie Propionibacterium acnesainsi qu’une réaction inflammatoire. La chronologie de ces événements reste incertaine. Cependant,l’activité de la glande sébacée et la qualité du sébum produits ont un rôle central dans cettepathogenèse et de fait sont sans doute le point de départ du développement de la pathologie.L’activité des sébocytes présents dans les glandes sébacées sont sous l’influence de nombreusesmolécules telles que des hormones, des facteurs de croissance ou des neuropeptides. La modificationdes taux de ces molécules chez le patient acnéique en comparaison aux sujets sains conditionne ledéveloppement de l’acné. Les androgènes et l’IGF-1 ont par exemple un rôle important dansl’apparition de l’acné à l’adolescence.Mais, ces mécanismes pathogéniques sont également sous l’influence de divers facteurs de risques(alimentation, stress, soleil, tabac…). Une mise au point des connaissances actuelles, de l’implicationet des mécanismes par lesquels le mode de vie et le patrimoine génétique influent sur ledéveloppement l’acné est présentée dans ce mémoireEnfin, il est également question de comprendre comment les médicaments permettent une réductiondes lésions d’acné, et de passer en revue les recommandations actuelles d’utilisation de cesmédicaments pour traiter le plus efficacement les patients acnéiques.
... The comedogenicity of a cosmetic can be determined in several ways including the use of a rabbit ear model 25 or via a cyanoacrylate biopsy on human subjects to determine the number follicles and microcomedones per square inch. 26 There is no universal industry standard for comedogenicity that determines the veracity of a "noncomedogenic" label. For the 29 products described as "noncomedogenic," the most common vehicles were lotions, followed by creams and ointments. ...
Importance:
Because moisturizer use is critical for the prevention and treatment of numerous dermatological conditions, patients frequently request product recommendations from dermatologists.
Objective:
To determine the product performance characteristics and ingredients of best-selling moisturizers.
Design and setting:
This cohort study involved publicly available data of the top 100 best-selling whole-body moisturizing products at 3 major online retailers (Amazon, Target, and Walmart). Products marketed for use on a specific body part (eg, face, hands, eyelids) were excluded.
Main outcomes and measures:
Pairwise comparisons of median price per ounce on the basis of marketing claims (eg, dermatologist recommended, fragrance free, hypoallergenic) and presence of ingredients represented in the North American Contact Dermatitis Group (NACDG) series were conducted using Wilcoxon rank sum tests. The effect of vehicle type (eg, ointment, lotion, cream, butter) was assessed using the Kruskal-Wallis test. Cross-reactors and botanicals for fragrances were derived from the American Contact Dermatitis Society's Contact Allergen Management Program database.
Results:
A total of 174 unique best-selling moisturizer products were identified, constituting 109 713 reviews as of August 2016. The median price per ounce was $0.59 (range, $0.10-$9.51 per ounce) with a wide range (9400%). The most popular vehicles were lotions (102 [59%]), followed by creams (22 [13%]), oils (21 [12%]), butters (14 [8%]), and ointments (3 [2%]). Only 12% (n = 21) of best-selling moisturizer products were free of NACDG allergens. The 3 most common allergens were fragrance mix (n = 87), paraben mix (n = 75), and tocopherol (n = 74). Products with the claim "dermatologist recommended" had higher median price per ounce ($0.79; interquartile range [IQR], $0.56-$1.27) than products without the claim ($0.59; IQR, $0.34-$0.92). Products with the claim "phthalate free" had higher median price per ounce ($1.38; IQR, $0.86-$1.63) than products without the claim ($0.59; IQR, $0.35-$0.91). Lotions (median, $0.49; IQR, $0.31-0.68) were statistically less expensive per ounce than butters (median, $1.20; IQR, $0.76-$1.63), creams (median, $0.80; IQR, $0.69-$1.25) and oils (median, $1.30; IQR, $0.64-$2.43). For products with a claim of "fragrance free," 18 (45%) had at least 1 fragrance cross-reactor or botanical ingredient. Products without any ingredients in the NACDG (median, $0.83; IQR, $0.47-$1.69) were not statistically more expensive per ounce than products with 1 or more allergens (median, $0.60; IQR, $0.35-$1.06).
Conclusions and relevance:
Best-selling moisturizers vary widely by price and product characteristics. Given the lack of readily available comparison data on moisturizer efficacy, dermatologists should balance consumer preference, price, and allergenicity in their recommendations.
... Otros factores de menor importancia son el uso de cosméticos y drogas con ingredientes comedogénicos, como lanolina y sus derivados, isopropil mistrato y sus análogos como isopalmitato, butil estearato, isopropil isostearato, entre otros, pigmentos rojos D y C (xanthene, monoazonilinas e indigoides) 41 que causan una obstrucción del flujo normal del sebo hacia la superficie, principalmente por la inducción de hiperqueratosis folicular 42,43 . Aunque la lista de condiciones asociadas al AC es larga, su etiología no está totalmente definida, convergiendo de esta manera en un modelo multifactorial. ...
Introducción: El acné conglobata (AC) es una forma infre-cuente de acné, caracterizada por desarrollo de un foco in-feccioso crónico, con manifestaciones inflamatorias locales severas, y pérdida de la estructura funcional de la piel, con abscesos confluentes y tejido cicatricial extenso. Descripción del Caso: Paciente masculino de 18 años de edad quien consulta por presentar lesiones cutáneas en cara y tórax de 6 meses de evolución, de carácter nodular, con sig-nos de flogosis y fistulizadas con secreción purulenta fétida, que dejan cicatriz. Previo a la consulta, las lesiones fueron tratadas con trimetropim/sulfametoxazol e ibuprofeno vía oral, y amikacina tópica, sin resultados satisfactorios. El cultivo bacteriológico de la secreción resultó positivo para Staphylococcus epidermidis y Streptococcus pyogenes; mientras que el estudio histopatológico confirmó el diagnóstico de AC con hallazgos de infiltrado inflamatorio crónico de la pared folicu-lar, y neutrófilos perifoliculares, en dermis superficial y pro-funda. Se inició el tratamiento con administración sistémica de moxifloxacina durante 2 semanas; y posteriormente se ini-cia uso tópico de eritromicina, clindamicina, y ácido azelaico, acompañados de isotretinoína vía oral. De manera paralela, se inicia manejo nutricional y psicológico de apoyo. Tras 2 meses de tratamiento se observa mejoría significativa de las lesiones, que se resuelven en su totalidad tras 6 meses. Discusión: El AC es una enfermedad que acarrea conse-cuencias física y psicosociales para el individuo que la pa-dece, especialmente en casos refractarios al tratamiento, el manejo apropiado de esta condición, incluye el correcto diagnóstico, y posteriormente el uso de antibioticoterapia y retinoides, así como terapia psicosocial. Palabras clave: acné conglobata, Staphilococcus ssp, iso-tretinoína, macrólidos, psicoterapia.
... In most formulations, many ingredients are present in lesser concentrations and combined chemically to create the fi nal product. Thus, comedogenic ingredients may not produce comedones in the fi nal formulation [ 10 ]. For this reason, it is not suffi cient to hand patients a list of comedogenic substances and assume that no problems will be encountered. ...
Dermatologists frequently encounter patients who are concerned about the effects of cosmetics and skin care products on their complexion. Since the course of acne waxes and wanes with hormonal influences, stress, and treatment interventions, it may be difficult to establish a cause and effect relationship. Patients may wonder whether the use of a certain moisturizer or cosmetic might result in worsening acne. This chapter deals with the issue of acne induction by skin care products and cosmetics, a condition termed acne cosmetica.
... Reputable manufacturers now generally test for ingredient and product comedogenicity and acnegenicity on human skin to the point that a nongreasy non-occlusive cosmetic made by such manufacturers is unlikely to be acnegenic. 12 Stingers (also described as hyperactive, intolerant, and irritable) were first described by Grove and colleagues. 13 Stingers sting, burn, prickle, tingle, or cause slight pain sensations primarily on the nasolabial folds and cheeks. ...
The validated hypoallergenic (vh) rating system was initiated in 1988 to try to objectively validate the "hypoallergenic" claim in cosmetics.
To show how the system rates cosmetic hypoallergenicity and to compare the prevalence of cosmetic contact dermatitis (CCD) among users of regular cosmetics versus cosmetics with high VH numbers.
(1) Made a VH list based on top allergens from patch-test results published by the North American Contact Dermatitis Group (NACDG) and the European Surveillance System on Contact Allergies (ESSCA); (2) reviewed global regulatory, cosmetic, drug, packaging, and manufacturing practices to show how allergens may contaminate products; (3) compared cosmetic ingredients lists against the VH list to obtain the VH rating (the more allergens absent, the higher the VH rating); and (4) obtained CCD prevalence among users of regular cosmetics versus users of cosmetics with high VH ratings.
(1) Two VH lists (1988, 2003) included only cosmetic allergens in the NACDG surveys, the third (2007) included cosmetic and potential contaminant noncosmetic allergens, and the fourth (2010) adds ESSCA patch-test surveys. (2) CCD prevalence is 0.05 to 0.12% (average, 0.08%) among users of cosmetics with high VH ratings versus 2.4 to 36.3% among users of regular cosmetics.
The VH rating system is shown to objectively validate the hypoallergenic cosmetics claim.
... Twice a day application of an effective moisturizer will increase skin hydration, corneocyte maturity and improve the underlying sub-clinical inflammatory changes because of external environment [56,77,78]. No correlation was found between cosmetic use and adult acne [79], but avoiding comedogenic compounds is advisable although the finished skin care products, even if they contain comedogenic ingredients, are not necessarily comedogenic [80]. It is important to select a well-formulated skin care product as follicles can be blocked temporarily following moisturizer use because of a decrease in sebum flow [81]. ...
Synopsis
The face is the most exposed part of our body, and deterioration of facial appearance, through disease or ageing, causes psychological distress. Acne lesions and subsequent pigmentation changes contribute to the unevenness of skin colour that is detrimental to facial attractiveness and leads to rejection and stigmatization in our society. The purpose of this review is to look at the root causes of premenstrual acne and, for the first time ever, propose that the specific timing of treatment can, at least in part, resolve the acne lesions. We postulate that it is the timing of the manual extraction that matters in resolving premenstrual acne and that the effectiveness of this therapy could be improved. Based on the reviewed evidence, we propose that it is important to remove the comedones at the time of ovulation, prior to the reduction of the size of the sebaceous orifice and epidermal barrier function, to counteract the onset of increased sebum production, prevent blockage of the pores and subsequent bacterial colonization and inflammation. If performed successfully, the extraction may contribute to a reduction in inflamed acne lesions and thus benefit women by increasing their facial attractiveness, well‐being, social function and thereby decrease psychological stress.
... This concept is particularly relevant to the skin of color patient, as oftentimes many darker-skinned patients will use opaque and oil-containing make-up to camouflage not only the acne, but more importantly, the PIH. However, recommending cosmetics may be difficult, as one study by Draelos et al 36 showed that cosmetic products containing comedogenic ingredients are not necessarily comedogenic. Patient evaluations of products can be helpful, but many times the only way to know whether an individual patient will not have a problem with a cosmetic is for the patient to use the product. ...
Acne vulgaris is one of the most common conditions for which all patients, including those with skin of color (Fitzpatrick skin types IV-VI), seek dermatological care. The multifactorial pathogenesis of acne appears to be the same in ethnic patients as in Caucasians. However, there is controversy over whether certain skin biology characteristics, such as sebum production, differ in ethnic patients. Clinically, acne lesions can appear the same as those seen in Caucasians; however, histologically, all types of acne lesions in African Americans can be associated with intense inflammation including comedones, which can also have some degree of inflammation. It is the sequelae of the disease that are the distinguishing characteristics of acne in skin of color, namely postinflammatory hyperpigmentation and keloidal or hypertrophic scarring. Although the medical and surgical treatment options are the same, it is these features that should be kept in mind when designing a treatment regimen for acne in skin of color.
ABSTRAK BB cream merupakan istilah dari blemish balm, blemish base, beblesh balm dan beauty balm di pasar barat yang dirancang menjadi alas bedak, pelembab dan tabir surya sekaligus. Penggunaan BB cream diduga ber hubungan bermakna dengan keparahan klinis akne vulgaris, karena penggunaan kosmetik ini dapat meningkatkan sebum akibat unsur komedogenik yang terkandung di dalam nya , seperti: lanolin, petrolatum , butyl stearate, lauryl alcohol dan oleic acid . Kandungan parfum seperti linalool, limonene, caffeine, geraniol, dan citral yang terkandung dalam BB cream juga dapat menyebabkan reaksi alergi dan iritasi sehingga meningkatkan risiko untuk terjadi nya akne vulgaris. Penelitian ini bertujuan untuk mengetahui potensi efek komedogenik dan iritasi akibat pemberian produk kosmetik BB cream pada telinga kelinci. Penelitian ini menggunakan desain true experimental laboratory dengan metode randomized post test only controlled group design. Penelitian ini menggunakan hewan coba kelinci New Zealand white jantan . D ilakukan aplikasi topikal 3 produk BB cream pada telinga kanan selama lima minggu sedangkan telinga kiri berfungsi sebagai kontrol negatif. Efek komedogenik dan iritasi dinilai berdasarkan skoring. Hasil uji statistik dengan menggunakan uji F isher exact didapatkan nilai p= 1,00 (p>0,05) , oleh karena itu disimpulkan bahwa tidak terdapat hubungan bermakna antara aplikasi topikal BB cream dengan pembentukan komedo dan perub a han iritasi pada kulit telinga kelinci . Kata Kunci: BB Cream, Akne Vulgaris, Komedogenik, Skoring Komedogenik, Skoring Iritasi ABSTRACT BB cream is a marketing term that stands for blemish balm, blemish base, beblesh balm and beauty balm. BB cream is designed to be foundation, moisturizer and sunscreen all at once. The use of BB cream is associated with the clinical severity of acne vulgaris, because the use of BB cream cosmetics can increase sebum production due to the comedogenic ingredients contained in it, such as lanolin, petrolatum, butyl stearate, lauryl alcohol and oleic acid. The perfume content such as linalool, limonene, caffeine, geraniol, and citral contained in BB cream could causes allergic reactions and irritation, thereby increasing the risk for acne vulgaris to occur. This study aimed to determine the comedogenicity dan irritation potency of BB cream cosmetic products applications on rabbit ears. This study used a true experimental laboratory design with a randomized post test only controlled group design method. This study used male New Zealand white rabbits as experimental animals. Topical application of 3 BB cream products was carried out on the right ear for five weeks, while the left ear function as a negative control. Statistical tests using Fisher's exact test obtained a value of p=1.00 (p>0.05). It is concluded that there was no significant relationship between the topical application of BB cream with the formation of comedones and changes in irritation of the rabbit ear skin. Keywords: BB Cream, Acne Vulgaris, Comedogenicity, Comedogenicity Scoring, Irritation Scoring
Objectives
Comedogenicity is a critical factor in making of cosmetics and skin care products. The term “acne cosmetica” was coined to link the relationship between female acne to the use of cosmetic formulations, stating that the ingredients used in the cosmetic formulations have the potential to evoke a comedogenic response or produce comedones. Therefore, it is important that a skin care product is non-comedogenic and efficacious at the same time. The main objective of this study is to evaluate the comedogenic potential of the test product (Venusia Max Cream – paraben free) when applied topically under occluded patch to the skin.
Material and Methods
This was a randomized, double-blinded, comparative study conducted in 24 healthy female participants, with prominent follicular orifices on the upper back region. Comedogenic potential of the test product (Venusia Max Cream – paraben free) was evaluated in comparison to positive (coconut oil) and negative (glycerin) controls in women. Each participant received topical application of test and control products under occluded patch to the skin on the upper aspect of the back, 3 times weekly for 4 weeks. Cyanoacrylate biopsies were performed before and after treatment to determine the microcomedones histologically. Microcomedones were graded using light microscopy and results were analyzed based on scale rating (0–3).
Results
The mean comedone grading was assessed between positive versus negative control, and positive control versus test product. The mean comedone grades were significantly less in test product 0.41 ± 0.50 and negative control 0.82 ± 0.73 in comparison to positive control 2.09 ± 0.68. The test product was least comedogenic in this study. Furthermore, no adverse events were reported during the study period.
Conclusion
Based on the histological evidence, Venusia Max Cream (paraben free) is a non-comedogenic, plant-based intense moisturizing cream and its use in regular skin care routine can be beneficial, particularly for acne prone and dry skin as it improves the skin hydration levels.
: Being commonly used skin care products, comedogenic potential of moisturizers should be assessed.
: The aim of the study was to evaluate the comedogenic potential of a moisturizer Venusia Max Lotion (paraben-, alcohol-, mineral oil-, animal origin-(PAMA) free) when applied topically to the skin compared to the controls.
: Double-blind, single-center, comparative study conducted at private institute in Mumbai, India
: Approximately 0.025 gm of the test product and 0.025 ml of positive control (coconut oil) and negative control (glycerin) were applied and occluded under a patch on the upper back of healthy female participants. Patch application and removal were made 12 consecutive times on alternate days for each participant. On the last day, approximately 2 hours after patch removal, a follicular biopsy was taken for all participants on all product application zones.
: Data analyzed with descriptive statistics using the SPSS software version 10.0.
: Data from a total of 19 participants was analyzed. The mean age was 35.32 years. The mean comedone grade for Venusia Max Lotion (PAMA free) was significantly lower compared to the positive control (Coconut Oil) (1.00 vs. 2.11, respectively; P=.001). The mean comedone grade was 0.79 for negative control (Glycerine) which is nearly similar to that of the test product.
The moisturizer product Venusia Max Lotion (PAMA free) is non-comedogenic as compared to positive control. Thus, it can be considered for moisturizing purposes without the fear of comedogenicity.
Background:
Many ingredients used in cosmetics evoke a comedogenic response. The concept of ''acne cosmetica'' was developed to link the use of certain ingredients to comedone formation. Various clinical research methods have been suggested for the effective screening of an ingredient that can worsen acne or acneiform eruption and confirm its clinical relevance as to whether it is used as a non-comedogenic claim. Although comedogenicity assessment has not yet been established, attempts have been made to evaluate the comedogenicity of cosmetic ingredients and find the most appropriate method to evaluate comedogenicity in human skin.
Materials and methods:
Total 6 participants were included in the study. Each participant received patches on the upper back containing cocoa butter. We used reflectance confocal microscopy (RCM) to count the number of microcomedones and follicles induced by cocoa butter.
Results:
The mean value change of microcomedone/follicle by the comedogenic substance was significantly higher than that of the non-applied site for 2 weeks (p = 0.0419). The mean value changes of the microcomedone diameter caused by the comedogenic substance were significantly larger than those found at the non-applied site at 2 and 4 weeks (p = 0.0026 and p = 0.0038, respectively).
Conclusions:
We recommend RCM as a non-invasive real-time method that is useful for evaluating comedogenicity and early detection of a microcomedone.
Acne vulgaris is a chronic, inflammatory, skin condition that involves the pilosebaceous follicles and is influenced by a variety of factors including genetics, androgen-stimulation of sebaceous glands with abnormal keratinization, colonization with Cutibacterium acnes (previously called Propionibacterium acnes), and pathological immune response to inflammation. Acne can occur at all ages and this discussion focuses on the first three decades of life. Conditions that are part of the differential diagnosis and/or are co-morbid with acne vulgaris are also considered.
Acne in the first year of life includes neonatal acne (acne neonatorum) that presents in the first four weeks of life and infantile acne that usually presents between 3 and 6 months of the first year of life with a range of 3 to 16 months after birth. Acne rosacea is a chronic, inflammatory, skin condition that is distinct from acne vulgaris, typically presents in adults, and has four main types: erythemato-telangiectatic, papulopustular, phymatous and ocular.
Treatment options for acne vulgaris include topical retinoids, topical benzoyl peroxide, antibiotics (topical, oral), oral contraceptive pills, isotretinoin, and others. Management must consider the increasing impact of antibiotic resistance in the 21st century. Psychological impact of acne can be quite severe and treatment of acne includes awareness of the potential emotional toll this disease may bring to the person with acne as well as assiduous attention to known side effects of various anti-acne medications (topical and systemic). Efforts should be directed at preventing acne-caused scars and depigmentation on the skin as well as emotional scars within the person suffering from acne.
Background:
Although Acne Vulgaris has a multifactorial etiology, comedogenesis and bacteria colonization of the pilosebaceous unit are known to play a major role in the onset of inflammatory acne lesions. However, many aspects remain poorly understood such as: Where and when is the early stage of the Propionibacterium acnes colonization in follicular unit? Our research aimed at providing a precise analysis of microcomedone's structure to better understand the interplay between Propionibacterium acnes and follicular units, and therefore the role of its interplay in the formation of acne lesions.
Methods:
Microcomedones were sampled using cyanoacrylate skin surface stripping (CSSS). Their morphology was investigated with multiphoton imaging and their ultrastructure with Scanning Electron Microscopy (SEM) and Transmission Electron Microscopy (TEM). Bacterial lipase activity in the microcomedones was quantified using a dedicated enzymatic test as well as a Fourier Transform Infra-Red (FTIR) analysis. The porphyrin produced by bacteria were analysed with HPTLC and fluorescence spectroscopy.
Results:
The imaging analysis showed that microcomedones' structure resembles a pouch, whose interior is mostly composed of lipids with clusters of bacteria and whose outer shell is made up of corneocyte layers. The extensive bacteria colonization is clearly visible using TEM. Even after sampling, clear lipase activity was still seen in the microcomedone. A high correlation, r=0.85, was observed between porphyrin content measured with HPTLC and with fluorescence spectroscopy. These observations show that microcomedones, which are generally barely visible clinically, already contains a bacterial colonization.
In this chapter, dealing with a variety of diseases looking like acne, a number of terminologies are used in the international literature, including acneiform, acneform, acne-like, and acne mimicking, in an analogous way.
The American Academy of Dermatology (AAD) has prioritized skin cancer prevention efforts in 2018, as photoprotection measures adopted by the general public remain suboptimal. A large proportion of patients lack understanding of primary prevention methods for skin cancer, and mistruths in advertising may contribute significantly to this deficit. Sunscreen labels are often stacked with multiple claims of seemingly high significance, making it difficult for patients to differentiate their validity when selecting a sunscreen. The United States Food and Drug Administration (FDA) published its monograph in 2011 to address these controversies in sunscreen labeling, but the reliability of several other claims remain unclear. In this article, we discuss several claims commonly made on sunscreen labels, and address the truths and mistruths surrounding them.
The concept of acne cosmetica was first introduced in 1972 to describe low-grade persistent acneiform eruptions in women who use cosmetics daily.¹ Although histologically similar to acne vulgaris, which forms from abnormal differentiation and proliferation of keratinocytes in the follicular duct, acne cosmetica comedones are smaller and closed and show less sebaceous gland involution.¹ Although sebum composition, follicular hyperkeratosis, androgens, and cytokines are implicated in the pathogenesis of acne vulgaris, acne cosmetica results from the prolonged use of cosmetic compounds that block follicular ducts. In 1972, 28% of adolescents and 4% of women (≥31 years of age) were affected.¹ We believe that the prevalence of acne cosmetica is increasing with cosmeceutical industry growth. Thus, comedogenicity is an important consumer consideration.
The Food, Drug, and Cosmetic Act defines drugs as products that cure, treat, mitigate or prevent disease, or affect the structure or function of the human body [1]. The dermatology and cosmetic industries recognize “cosmeceuticals” as cosmetics that have drug-like benefits. The term “cosmeceutical” was first used by Dr. Albert Kligman to describe a cosmetic product that exerts a therapeutic benefit in the appearance of the skin, but not necessarily a biologic effect on skin function, which would then classify it as a drug [2–4]. The Food and Drug Administration does not recognize or regulate cosmeceuticals. The symbiotic relationship between a drug and a cosmetic has become increasingly evident with the rapid growth of the cosmeceutical industry over the last decade. There are now both prescription cosmeceuticals and over-the-counter cosmeceuticals available to consumers. This arbitrary distinction varies in different countries. For example, drugs such as tretinoin, available only by prescription in the United States, are sold as over-the-counter cosmeceuticals in Central America. Antiperspirant is also regulated as a drug in the United States while being considered a cosmetic in Europe.
Despite the low amount of complaints from consumers that experience acne after using cosmetics, it is possible to get valuable information in order to provide better products. Cosmetics are very popular and once it is considered safe, their use continues to increase. However, during recent decades, we have become aware that adverse effects can occur. According to the Brazilian Society of Dermatology, acne is the main reason why Brazilians visit the dermatologist. This disease affects all to a certain degree and induces significant psychosocial consequences. However, there are few data about its epidemiology and how products can influence this condition. A structured vigilance system is a valuable tool for monitoring the safety profile of products, for information purposes and for product improvement, as well as meeting the requirements of health authorities and consumers. The objective was to determine the consumer characteristics and whether there was any time effect or product type effect. 66 face products (makeup foundation and powder, sunscreen and face treatment products) were chosen to access the characteristics of the population that complains about acne after using cosmetics. Cosmetovigilance reports from November 2010 to August 2012 were analyzed. Only spontaneous reports of Brazilian consumers related to acne were considered. The data related to product category was based on notification rate (number of complaints received per unit of product sold). Other parameters were based on percentage of reports. Descriptive statistics and exploratory analysis were done using the software XLSTAT, 2012. The confidence interval of 95% was used. Results and Discussion The number of reported adverse reactions is very low, probably because of underreporting. According to our results, adverse effects occur in the first month of product use, during the first applications. The consumer is totally recovered in a short period after discontinuing it. Women (98%) complain more than men. 39% of the complaints belong to people from 26 to 35 years old, while 25% represents people from 36 to 45 years old. 18% of the consumers that complain are older than 45 years old and 7% are younger than 25 years old. There are more complaints from the Southeast Region of Brazil (73.7%), followed by the South (14.7%), Northeast (5.5%), Midwest (5.3%) and North (1%). The product category that has more complaints is face care (Notification rate – 0.024%), followed by makeup products (0.015%) and sunscreens (0.002%). It could happen because exposure to makeup and sunscreen is punctual and usually concomitant with other face products. In contrast, face treatment products are mostly used daily, which means a greater exposure. Figure 2: Percentage of Complaints related to Acne Adverse Effects by Region in Brazil 0 0.05 0.1 0.15 0.2 0.25 Notification Rate (%) References
Salicylzuur heeft geen plaats in de behandeling van acne.
Orale anticonceptiva met cyproteronacetaat worden niet langer aanbevolen.
Doxycycline is het eerste keus oraal antibioticum in plaats van tetracycline.
Pomade acne (aka acne venenata) is considered a clinically distinct entity from the more common acne vulgaris. It is caused by the use of pomades applied to the hair and scalp in individuals of African descent with tight curly hair. Pomades are oil- or ointment-based hair care products used to lubricate the scalp and improve manageability of the hair. Pomade acne consists mainly of uniform, closely set comedones predominantly of the forehead and temple region. Involvement of the cheeks and ears has been documented as well [1]. It is said to be associated with little to no infl ammation [2] which is in stark contrast with the comedones of acne vulgaris in which Halder et al. histologically found a marked infl ammatory response in individuals with skin of color [3]. These lesions are primarily follicular and considered to be of very slow onset. Characteristically, pomade acne is limited to the comedonal stage but infl ammatory papules, pustules, miliary cyst, and an erythematous and edematous phase have all been documented [1,2].
Background: A topical trolamine/sodium alginate emulsion (TAE) promotes the healing of damaged skin. However, the repeated administration of any topical product increases the potential of contact dermal sensitization and comedogenicity, particularly when applied to the face. Objective: Two studies to determine whether repeated applications of the TAE induce microcomedones or contact dermal sensitization in healthy volunteers were conducted. Methods and Materials: For the comedogenicity study, the TAE was applied to the upper back 12 times at 48-hour to 72-hour intervals and compared with negative control sites. Sites were graded for irritation and follicular biopsies were taken. The size and number of microcomedones were assessed. The dermal sensitization study was comprised of 2 phases: an induction phase including 9 applications of the TAE on the left side of the back for approximately 3 weeks; and after a 2-week rest period, a challenge phase in which a single patch application was placed on a new test site, removed 24 hours later, and assessed at 24, 48, 72, and 96 hours. Results: The difference between the mean comedogenicity scores for the TAE (0.65) and the negative control (0.79) was not statistically significant (P≤.05). In the dermal sensitization study, 2 subjects reported low-level, transient reactions graded ± or 1(North American Contact Dermatis Group grading scale); 1 subject reported a grade +1 reaction with edema; and another a grade +2 edema reaction. During the challenge phase, 4 subjects exhibited low-level, transient reactions graded ± or 1. Conclusions: The topical TAE did not induce clinically significant dermal sensitization or microcomedones in healthy volunteers under repetitive test patch conditions.
Acne is a condition that is impacted to a greater or lesser degree by all substances that touch the skin surface. Sebum, eccrine secretions, bacteria, cosmetics, cleansers, and moisturizers all impact the skin of patients afflicted with acne. While prescription dermatologic care remains the mainstay of acne therapy, an important contribution to the success or failure of acne treatment is the concomitant use of cleansers and cosmetics. This chapter examines over-the-counter (OTC) cleansers and cosmetics in the framework of acne treatment. The discussion opens with an evaluation of cleansers to include surfactants, various cleanser forms, and active ingredients incorporated into OTC cleansers to assist the dermatologist in formulating cleanser recommendations to patients. Following the use of cleansers, acne patients may wish to use moisturizers to counter the dryness and flaking that inevitably accompanies the use of topical acne medications containing skin irritants, such as benzoyl peroxide and/or retinoids. Finally, the realm of colored cosmetics is presented to provide ideas for the selection of facial foundations, powders, and ancillary colored facial products in the acne patient who may desire camouflaging, but must select products that do not worsen the facial acne.
Many ingredients used in cosmetics evoke a comedogenic response. Rabbit ear model (REM) is a useful method that can replace human in examining materials and products in early developmental stage. However, a number of studies pointed out its disadvantage that it overreacts to comedogenic materials. The purpose of this study was to find the most appropriate region for evaluating comedogenicity in human skin.
Sixty-six female subjects (age 32.48 ± 10 years; range 20-52 years) with mild to moderate facial acne lesions were included in this study. The whole face, upper chest, and back of volunteers were photographed. Lesion (closed and open comedones) counting, instrumentation of sebum secretion level, and analysis of porphyrin number were performed. The entire study was performed under environmental conditions of specific relative temperature and humidity, controlled and maintained identically for each volunteer.
In case of closed comedone, forehead showed a significant correlation with frontal cheek, lateral cheek, chin, and upper back. Meanwhile, significant correlations were observed between frontal cheek and chin as well as lateral cheek and chest. As for open comedone, forehead showed a significant correlation with chin site. A significant correlation was also observed between front cheek and lateral cheek as well as between upper chest and back. Analyzing the correlation between the occurrence of comedones and sebum in each region, a significant correlation between closed comedone and sebum was observed in frontal and lateral cheek. Analyzing the correlation between the occurrence of comedones and porphyrine in each region, a significant correlation between open comedone and porphyrin was observed in chin.
When evaluating the comedogenicity of cosmetics ingredients or products, this study recommends using both of the methods of testing on back and directly testing on face according to the characteristics of the materials. In case of mild potent ingredients or products in particular, verification through usability test that the directly test on face will help securing reliability.
© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Occupational and environmental acne includes oil acne, coal-tar and pitch acne, acne cosmetica, acne aestivalis (from sun), acne mechanica, tropical acne, and chloracne. Chloracne is a refractory acneiform eruption clinically characterized by comedones and straw-colored cysts. The comedones predominantly affect the malar region of the cheek and the retroauricular areas. Although chloracne is rare, it is a sensitive indicator of chemical exposure to certain polyaromatic halogenated hydrocarbons and may be associated with internal poisoning that should be recognized by physicians treating occupational skin disease. Patients with the cutaneous manifestations of chloracne should be carefully investigated for systemic complications (such as hepatic, ophthalmic, neurologic, lipoprotein, and endocrine abnormalities).
Adult acne is becoming recognized as a unique form of acne including either early (adolescent) acne that remains persistent or late onset acne. Women are predominantly affected in adult acne and will be focus of this review. The epidemiology and the characteristics of adult acne are discussed including clinical differences between adolescent and adult acne. We review topical therapies such as antibiotics, retinoids, dapsone, azelaic acid and combination-based therapies. We also review systemic therapeutic considerations, including antibiotics, isotretinoin, oral contraceptives, and hormonal modulators. We discuss the use of light-based therapies such as visible light and photodynamic therapy. Alternative therapies such as the use of botanical and phytochemical therapies are reviewed as well. Finally, we discuss the clinical and laboratory screening for considering polycystic ovarian syndrome when evaluating adult women with acne.
Cosmetics are products which are intended to be used for cleaning, perfume or enhancing appearance. The face foundations and face powder has a very high consumption rate. However, cosmetics composed of different chemical materials which may interact together and become harmful to the skin. The current survey is focusing onto a possible problems might be encountered throughout the use of face powders in Tripoli areas, Libya. This perception and assessment survey has been applied using closed end questionnaire. The sample of study was circulated over 170 female participants and 91.8% percent of them provided clear and obvious participation. The results showed over 66.6% of participants suffered from problems as a result of applying a face powder. Problems appeared was dryness is 56.7%, irritation is 29.8%, Acne is 26.9% and Spots is 16.3%. The market screening at Tripoli showed more than 25 brands of face powder from different origins, the most popularly used were Nibo, Pupa, Max Factor and Deborah. The four mentioned problems appeared with Nibo and Pupa, dryness and spots appeared with Deborah, and just dryness appeared with Max Factor. In conclusion our results, although give information on many health problems encountered during the use of face powder from different sources on what the participants responses, and due to the relative large incidence of problems mentioned, the need of a system able to report, evaluate, withdraw of harmful cosmetics partially or totally cannot be ignored.
Background:
Case-control studies to support the concept of acne cosmetica are lacking.
Objective:
To examine the association of post-adolescent acne with the use of cosmetics and cosmetic procedures.
Methods:
910 post-adolescent patients with acne and an equal number of matched controls were studied for exposure to cosmetics and cosmetic procedures. A cumulative cosmetic exposure index was stratified into four quarters of increasing exposure.
Results:
Comparison of different cumulative exposure categories with the lowest exposure category (multivariate analysis, logistic regression) showed that the odds ratios, which were always <1, progressively declined as cosmetic exposure increased [odds ratios (95% confidence intervals): 0.679 (0.501-0.922), 0.355 (0.258-0.487), 0.307 (0.217-0.433)]. However, some individual cosmetics had odds ratios >1.
Conclusion:
Overall cosmetic use was negatively associated with post-adolescent acne. The term 'acne cosmetica' is appropriate in the sense that some cosmetics may cause acne.
This work is aimed to evaluate the application of photoacoustic spectroscopy (PAS) in the characterization of inclusion complexes of benzophenone-3 (BZ-3) and hydroxypropyl-β-cyclodextrin (HPCD) and to analyze the ex vivo percutaneous penetration of sunscreens and their reaction with the skin. The formation of inclusion complexes of BZ-3 and HPCD was performed by co-precipitation in stoichiometric ratios of 1:1 and 1:2. Thermal analysis and PAS characterized these inclusion complexes, and they indicated that the stoichiometric ratio of 1:2 was best. Sunscreen formulations were prepared and applied on the ears of rabbits. PAS suggested that the formulation with the complex resulted in lower penetration of BZ-3. Histological analysis demonstrated that the use of the formulation with BZ-3 was associated with an increase in the comedogenic effect and the presence of acanthosis, while no such effect was found in the formulation with the complex. The formulation with the BZ-3-HPCD complex is a promising strategy for improving the photoprotective effect of BZ-3. PAS can be used in the study of inclusion complexes with cyclodextrins and the evaluation of the percutaneous penetration of sunscreen formulations. Further tests are being conducted using PAS to monitor in vivo changes in the optical absorption spectra of formulations and to investigate their photostability.
Appropriate cosmetics for skin cleansing are capable of contributing to a reduction of especially inflammatory lesions in acne-prone patients and to support pharmacological intervention in patients with manifest acne. Cleansing of acne-prone skin should employ acidified synthetic cleansers with a pH of 5.5 rather than soap. Furthermore, the ingredients of certain skin care products, i.e. nicotinamide, lactic acid, triethyl acetate/ethyllineolate, and prebiotic plant extracts, affect different mechanisms of acne pathogenesis and therefore may contribute to a decrease in acne lesions. At least some of these ingredients underscore the concept of evidence-based cosmetics. In contrast, the problem of acne lesions caused by comedogenic ingredients in cosmetics today is negligible.
• Substances that are moderately to strongly comedogenic in the rabbit ear model test have been found to be capable of inducing comedones in the human model described in this report. The test substances are applied under occlusion for one month to the upper part of the backs of young adult, black men who have large follicles. The degree of follicular hyperkeratosis is assessed by a noninvasive "follicular biopsy" technique, employing a fast-setting cyanoacrylate glue to remove the follicular contents. The rabbit model is more sensitive than the human. Substances that are weakly comedogenic in the rabbit are probably safe for human use with the possible exception of acne-prone persons.
(Arch Dermatol 1982;118:903-905)
Low-grade, persistent acneiform eruptions of small comedones with occasional papulopustules occur in one third of adult women. This study imputes cosmetics as the cause of this disorder which has been named acne cosmetica.
Half of 25 facial cosmetic creams were found to be mildly comedogenic when tested in rabbits' external ear canals. Substances which are common constituents of cosmetics were also comedogenic, namely, lanolin, petrolatum, certain vegetable oils, and pure chemicals such as butyl stearate, lauryl alcohol, and oleic acid.
These materials were only weakly comedogenic in relation to potent acnegens such as tars and chlorinated oils. Daily use for years can evoke lowgrade comedonal reactions in susceptible women. More active cosmetics induced subclinical comedones when applied occlusively to backs of men.
Synopsis The external ear canal of the rabbit has been utilized to assess the comedogenic potential of ingredients used in the formulation of products applied to the skin. Some cosmetic raw materials have been shown to produce varying degrees of hyperkeratosis in the pilosebaceous unit of this animal model. With test results previously reported on vegetable oils, fatty acid esters, lanolins, surfactants, and other ingredients, there appear to be discrepancies in findings between investigators. The present study expands on information relating to the comedogenic potential of cosmetic components, and reevaluates the activity of several substances previously reported.
A simplified comedogenic assay is described in which test materials are applied for 2 weeks to the ears of rabbits just external to the ear canal. Excised tissue is thus immersed in water at 60 degrees C for 2 min, yielding a sheet of epidermis with microcomedones attached. The magnitude of follicular hyperkeratosis is extracted with the stereomicroscope. Sixteen materials were evaluated by the new and old model which required histological sectioning. Agreement was excellent.
Substances that are moderately to strongly comedogenic in the rabbit ear model test have been found to be capable of inducing comedones in the human model described in this report. The test substances are applied under occlusion for one month to the upper part of the backs of young adult, black men who have large follicles. The degree of follicular hyperkeratosis is assessed by a noninvasive "follicular biopsy" techniques, employing a fast-setting cyanoacrylate glue to remove the follicular contents. The rabbit model is more sensitive than the human. Substances that are weakly comedogenic in the rabbit are probably safe for human use with the possible exception of acne-prone persons.