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Efficacy of 10% Azelaic Acid Gel with Hydro-alcoholic or Alcohol-free Bases in Mild to Moderate Acne Vulgaris; the First Clinical Trial
Abstract
Azelaic Acid is a very effective topical medication for treating acne vulgaris. This study aims to compare the efficacy of 10% azelaic acid gel with hydro-alcoholic and alcohol-free bases in mild-to-moderate acne vulgaris. This randomized, double blind, clinical trial, 40 patients with mild-to-moderate acne vulgaris were recruited from Sina Hospital from November 2009 through March 2011. They randomized in two equal age and sex-matched groups, receiving 10% azelaic acid gel with either hydro-alcoholic base or alcohol-free base once at night on their face for eight consecutive weeks. All the patients were revisited on weeks 1, 2, 4, 6 and 8 after treatment and facial acne lesions were counted on each session. Possible complications, as well as the effect of skin type were investigated. Total, inflammatory and noninflammatory acne lesion counts decreased significantly in both groups by the end of study period. However, there was no significant difference between the two groups in this regard (p<0.05). There were minor, self-limited complications, including 3 cases of mild itching in both groups. For the count of inflammatory lesions, azelaic gel with alcoholic base was significantly more effective than azelaic gel with alcohol-free base in patients with oily facial skin (p = 0.02). All the patients (100%) were very satisfied with their treatments. In conclusion, both 10% azelaic gels with hydro-alcoholic and alcohol-free bases were comparably effective against mild-to-moderate acne vulgaris. In patients with oily skin, however, 10% azelaic acid with hydro-alcoholic base was superior to the medication with alcohol-free base in patients with oily skin.
... AzA, in its prescription concentration of 15% and 20%, is thought to be effective in acne due to its anti-inflammatory activities, its ability to inhibit growth of C. acnes, and its mild keratolytic As monotherapy, in a small uncontrolled, 8-week study of patients with mild-to-moderate acne, once-daily application of a 10% AzA gel resulted in significant reduction in inflammatory lesions and non-inflammatory lesions. 22 As adjunctive therapy, use of AzA 5% with erythromycin 2% was more effective than monotherapy with erythromycin 2% or 20% AzA in a randomized, double-blind, 12-week study of 147 patients with mild-to-moderate acne. 23 The combination product was better tolerated than the 20% AzA. ...
Importance
Acne and rosacea have substantial implications for quality of life, and it is therefore important to ensure the patient’s voice is being captured in pivotal randomized clinical trials (RCTs). Although patient-reported outcome measures (PROMs) are a valuable tool to capture the patient perspective, little is known about use of PROMs in RCTs on acne and rosacea.
Objective
To characterize the use of PROMs in RCTs on acne and rosacea.
Evidence Review
A systematic literature search was conducted using the search terms acne vulgaris and rosacea in the following databases: MEDLINE through PubMed, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. A modified search hedge for RCTs from the McGill Library was applied. All phase 2, 3, and 4 RCTs published between December 31, 2011, through December 31, 2021, that evaluated the efficacy and safety of therapies for acne and rosacea vs any comparator were eligible for inclusion.
Findings
A total of 2461 publications describing RCTs were identified, of which 206 RCTs met the inclusion criteria (163 trials [79%] on acne and 43 [21%] on rosacea). At least 1 PROM was used in 53% of trials (110) included; PROM use was more common in rosacea RCTs (67% [n = 29]) compared with acne RCTs (50% [n = 81]). At least 1 dermatology-specific (13% [n = 27]) or disease-specific (14% [n = 28]) PROM was included in the RCTs analyzed. Only 7% of trials (14) included a PROM as a primary outcome measure. There was no statistically significant increase in PROM inclusion over the study period (11 of 21 trials in 2011 vs 5 of 12 trials in 2021).
Conclusions and Relevance
In this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period. In addition, PROMs were rarely used as a primary outcome measure, and inclusion of PROMs has not increased substantially over the past 10 years. Increasing use of PROMs in RCTs can ensure that the patient’s perspective is captured during the development of new treatments for acne and rosacea.
Background: Acne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear.
Objectives: To assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne.
Search methods: We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers.
Selection criteria: Clinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life.
Main results: We included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA. The vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years. We assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias. We grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events. Azelaic acid In terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). Low-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). In terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of azelaic acid versus tretinoin, but individual application site reactions were reported, such as scaling. Salicylic acid For PGA, there may be little or no difference between salicylic acid and tretinoin (RR 1.00, 95% CI 0.92 to 1.09; 1 study, 46 participants; low-quality evidence); we are not certain whether there is a difference between salicylic acid and pyruvic acid (1 study, 86 participants; very low-quality evidence); and PGA was not measured in the comparison of salicylic acid versus benzoyl peroxide. There may be no difference between groups in withdrawals when comparing salicylic acid and pyruvic acid (RR 0.89, 95% CI 0.53 to 1.50; 1 study, 86 participants); when salicylic acid was compared to tretinoin, neither group had withdrawals (both based on low-quality evidence (2 studies, 74 participants)). We are uncertain whether there is a difference in withdrawals between salicylic acid and benzoyl peroxide (1 study, 41 participants; very low-quality evidence). For total minor adverse events, we are uncertain if there is any difference between salicylic acid and benzoyl peroxide (1 study, 41 participants) or tretinoin (2 studies, 74 participants) (both very low-quality evidence). This outcome was not reported for salicylic acid versus pyruvic acid, but individual application site reactions were reported, such as scaling and redness. Nicotinamide Four studies evaluated nicotinamide against clindamycin or erythromycin, but none measured PGA. Low-quality evidence showed there may be no difference in withdrawals between nicotinamide and clindamycin (RR 1.12, 95% CI 0.49 to 2.60; 3 studies, 216 participants) or erythromycin (RR 1.40, 95% CI 0.46 to 4.22; 1 study, 158 participants), or in total minor adverse events between nicotinamide and clindamycin (RR 1.20, 95% CI 0.73 to 1.99; 3 studies, 216 participants; low-quality evidence). Total minor adverse events were not reported in the nicotinamide versus erythromycin comparison. Alpha-hydroxy (fruit) acid There may be no difference in PGA when comparing glycolic acid peel to salicylic-mandelic acid peel (RR 1.06, 95% CI 0.88 to 1.26; 1 study, 40 participants; low-quality evidence), and we are uncertain if there is a difference in total minor adverse events due to very low-quality evidence (1 study, 44 participants). Neither group had withdrawals (2 studies, 84 participants; low-quality evidence).
Authors' conclusions: Compared to benzoyl peroxide, azelaic acid probably leads to a worse treatment response, measured using PGA. When compared to tretinoin, azelaic acid probably makes little or no difference to treatment response. For other comparisons and outcomes the quality of evidence was low or very low. Risk of bias and imprecision limit our confidence in the evidence. We encourage the comparison of more methodologically robust head-to-head trials against commonly used active drugs.
European evidence-based (S3) guideline for the treatment
of acne – update 2016 – short version
This is a short summary of the complete version of the S3 European
Acne guideline, please see online appendix for full text
(Document S1. Long Version) and detailed methods report
(DOI: 10.1111/jdv.13783). Expiry date: 31 December 2020
Methods
In order to weight the different recommendations, the group
assigned a ‘strength of recommendation’. It considered all
aspects of the treatment decision, such as efficacy, safety,
patient preference and the reliability of the existing body of
evidence.
JEADV 2016, 30, 1261–1268 © 2016 European Academy of Dermatology and Venereology
Acne vulgaris is an inflammatory disease of the pilosebaceous units. Various systemic and topical options are available for its treatment.
This study aimed to evaluate the efficacy of 2% metronidazole gel in acne vulgaris.
Double-blind, randomized, placebo-controlled, split-face clinical trial. Seventy young adults with moderate acne vulgaris received 2% metronidazole gel on the right side of their face and placebo on the left side of their face twice daily for 8 weeks. The number of inflamed and noninflamed facial lesions and side effects of treatment were documented on weeks 1, 2, 4, and 8. The patients' overall satisfaction was recorded at the end of the study. For statistical analysis we used the repeated-measures analysis, the chi-square test, Fisher's exact test, and the independent-samples t-test as appropriate.
Counts of inflamed and noninflamed facial lesions were comparable between the two sides at baseline. The number of the lesions was significantly lower on the metronidazole-treated side at all follow-up visits. Erythema and oily face decreased by 85.7% and 87.1%, respectively, on the metronidazole-treated side. Mild burning sensation and dryness on the metronidazole-treated side was reported by 3.4% and 22.9% of the patients, respectively. Eighty-eight percent of the patients were satisfied with the results of treatment on the metronidazole-treated side.
Metronidazole gel (2%) is an effective, safe, and well-tolerated topical medication for moderate acne vulgaris.
Acne vulgaris is a common problem, particularly among adolescents, which is usually resistant to monotherapy. We evaluated the efficacy and safety of a combination of azelaic acid (AA) 5% and erythromycin 2% gel (AzE) compared with AA 20% or erythromycin 2% gels in facial acne vulgaris.
We conducted a 12-week, multicenter, randomized double-blind study on 147 patients with mild-to-moderate acne vulgaris. Four treatment group were determined (placebo, erythromycin, AA and AzE) and followed in 4-week intervals for 12 weeks, except the placebo group which was changed to routine treatment after 4 weeks.
The combination of AA 5% and erythromycin 2% gel significantly reduced the number of papules, pustules and comedones compared with placebo (p < 0.001), erythromycin 2% (p < 0.01) or AA 20% (p < 0.05). The incidence of adverse effects observed in patients treated with AzE (27%) was less than that with erythromycin 2% (54%) and AA 20% (45%).
The combination of AA 5% and erythromycin 2% produced more potent therapeutic effects in comparison with erythromycin 2% or AA 20% alone, and with fewer side effects.
The primary aim of the study was to establish the clinical efficacy and safety of a combined treatment consisting of topical 20% azelaic acid (AA) cream and the oral antibiotic minocycline in the therapy of severe inflammatory acne (nodular papulopustular acne and acne conglobata) in a comparison with oral isotretinoin therapy. The secondary aim was to establish the value of AA cream as maintenance therapy in the prevention of recurrent acne.
This open-label but randomised study involved 85 patients with nodular papulopustular acne or acne conglobata (Leeds grading scale > 4) who were treated for 6 months. In an immediately subsequent 3-month second phase, eligible patients from the initial combination group used the AA cream as maintenance therapy, while the eligible patients from the isotretinoin group served as untreated control.
A 6-month course of treatment with topical 20% AA cream plus oral minocycline in 50 patients proved to be effective in nodular forms of acne (median reduction of facial comedones: 70%; of papules and pustules: 88%; of deep inflammatory acne lesions: 100%). Overall, the combined treatment was not quite as effective as treatment with oral isotretinoin (35 patients; reduction of comedones: 83%; of papules and pustules: 97%; of deep inflammatory acne lesions: 100%). In the 3-month maintenance therapy phase, about half of the patients who received AA monotherapy maintained the very good facial result achieved by the end of phase I. A similar rate was found in the patients of the isotretinoin group, who received no further active acne treatment. In the other 50% of patients, differences existed between the groups as regards the degree of deterioration: Marked deterioration occurred more frequently under AA treatment, while only slight deterioration was more frequent in the isotretinoin group. The combination was tolerated much better than isotretinoin. The incidence of local side effects observed under the combination of AA and minocycline (36.5%, mainly transient burning and itching of mild or moderate intensity) was considerably lower than that seen with isotretinoin (65.7%). The rate of local side effects of marked intensity observed under the combination, i.e. 6%, was well within the range of 5-10% previously reported for AA. The incidence of systemic side effects was lower (8%, mainly gastrointestinal symptoms) under the combined therapy than under isotretinoin (14.3%).
The combination of topical 20% AA cream and oral minocycline is an highly effective treatment in severe forms of acne. It is better tolerated and associated with fewer risks than oral isotretinoin - in particular, there is no risk of teratogenicity. The combination can be regarded as a valuable alternative in patients for whom isotretinoin is not indicated, who do not wish to use or can not tolerate isotretinoin therapy and particularly in female acne patients of child-bearing potential. Topical 20% AA cream can be used successfully as maintenance therapy to prolong the recurrence-free interval.
During the last 20 years, the number of topical and systemic drugs for the treatment of acne vulgaris has been enriched. Topical drugs on the one hand have been newly discovered or further developments of already available agents such as in the group of retinoids or galenic formulation have improved efficacy or local tolerance. Topical retinoids are a mainstay in acne treatment since 1962. All-trans retinoic acid was the first and is still in use. Its irritative potential has led to the new galenics, i.e. incorporation in microsponges and in propolyomers, which increased the tolerability significantly. The isomer of tretinoin, isotretinoin, has the same clinical efficacy, but also a lower irritancy. A real breakthrough was adapalene, a retinoid-like agent, with a different retinoid receptor-binding profile, but in addition to the same clinical efficacy on inflammatory and non-inflammatory acne lesions compared to tretinoin, a better tolerability and, therefore, compliance. Unfortunately, over the past years topical retinoids have been less used in inflammatory acne than they should be, taking the the mechanisms of action into account. Topical antimicrobials, in particular topical antibiotics, should be used less often than in the past and only for short periods to avoid the development of resistances. It seems better to combine those agents with topical retinoids, with BPO or with azelaic acid to enhance the efficacy and slow down the development of resistance. BPO is still the gold standard for papular-pustular acne of mild-to-moderate type in concentrations of 2-5%. Azelaic acid is an alternative with efficacy on the comedo and is antibacterial without development of resistances. Finally, the physical removal by electrocautery or CO(2) laser of multiple densely packed closed comedones, macrocomedones and microcysts is necessary to enhance the efficacy of topical comedolytic agents and to speed up the therapeutic results. Photodynamic therapy has not yet been proven efficacious in controlled studies. Blue and red light can probably be used in association with local agents but enhancement of the irritative potential of topical and systemic agents has to be considered.
Nicotinamide and clindamycin gels are two popular topical medications for acne vulgaris. This study aimed to compare efficacy of the topical 4% nicotinamide and 1% clindamycin gels in these patients. In this randomized, double-blind clinical trial, patients with moderate inflammatory facial acne vulgaris were randomly allocated to receive either topical 4% nicotinamide (n = 40) or 1% clindamycin gels (n = 40) twice daily. In each group, they were further categorized in two subgroups with oily and non-oily types of facial skin. The Cook's acne grade was determined at baseline and at weeks 4 and 8 post treatment. Acne grade decreased from an average of 5.93 ± 0.83 at baseline to 4.03 ± 1.33 at week 4 and 2.08 ± 1.59 at week 8 in nicotinamide receivers, and from an average of 5.70 ± 0.94 at baseline to 3.85 ± 1.66 at week 4 and 2.03 ± 1.53 at week 8 in the clindamycin group (within-group P < 0.001, between-group P > 0.05). Comparing with each other, nicotinamide and clindamycin gels were significantly more efficacious in oily and non-oily skin types, respectively. No major side effect was encountered by any patient. Skin type is a significant factor in choosing between topical nicotinamide and clindamycin in patients with acne vulgaris.
ABSTRACT Berberis vulgaris L. (barberry) is a very well-known herb in traditional medicine. Apart from its anti-inflammatory and antibacterial properties, the antilipogenic effect of barberry on the sebaceous glands in animals may further suggest it could be employed as an anti-acne agent. This study examined the effect of oral aqueous extract of barberry on acne vulgaris. Adolescents aged 12-17 years with moderate to severe acne vulgaris were randomly given oral gelatin capsules containing either aqueous extract of dried barberry (600 mg daily for 4 weeks, n = 25) or placebo (n = 24). Counts of facial noninflamed, inflamed, and total acne lesions, as well as the Michaelson's acne severity score were documented at baseline and at weeks 2 and 4. Both groups were comparable in terms of the patients' characteristics and baseline variables. After 4 weeks, the mean number of noninflamed, inflamed, and total lesions as well as mean Michaelson's acne severity score declined significantly by 43.25 ± 10.88% (median: 42.11%), 44.53 ± 11.78% (median: 45.45%), 44.64 ± 8.46% (median: 46.15%), and 44.38 ± 8.25% (median: 44.07%), respectively, among the extract receivers (p <.001 for all the changes). Similar changes were not significant in the placebo group. No notable complication or side effect was reported in relation to barberry. In conclusion, oral aqueous extract of dried barberry is a safe, well-tolerated, and effective choice in teenagers with moderate to severe acne vulgaris.
Acne vulgaris is the most common dermatological disorder in adolescence and young adults. In past decades, systemic antibiotics have had the main role in the treatment of acne patients with inflammatory papules and cysts. They are sometimes associated with side effects, contributing to reduced compliance.
This study aimed at comparing the efficacy and safety of oral azithromycin and doxycycline in the treatment of moderate acne vulgaris, considering the age of patients as an influencing parameter.
In a randomized, double-blind, clinical trial, 100 patients with moderate acne vulgaris who attended the outpatient dermatology clinic were evaluated during a 15-month period. They were randomized into two equal groups: A and D. Patients in group A received oral azithromycin (500 mg daily, 4 consecutive days per month for 3 consecutive months) and patients in group D took doxycycline (100 mg daily for 3 consecutive months). The number and types of lesions (all over the body) were determined at baseline and at the end of each month for 90 days afterwards. Michaelson's acne severity score was also determined at baseline and at the end of the third month after initiating treatment. Patients were followed up for another 3 months after discontinuation of treatment to determine the recurrence rate. Results: Both antibiotics were comparably effective in the treatment of moderate acne vulgaris. There was no significant side effect in the A group and the complications were minor in the D group. Doxycycline was significantly more effective in patients older than 18 years.
Azithromycin is at least as effective as doxycycline in the treatment of moderate acne vulgaris; however, in patients older than 18 years doxycycline is better.
Azelaic acid is a naturally occurring saturated dicarboxylic acid which, on topical application (usually as a 20% cream), has been shown to be effective in the treatment of comedonal acne and inflammatory (papulopustular, nodular and nodulocystic) acne, as well as various cutaneous hyperpigmentary disorders characterised by hyperactive/abnormal melanocyte function, including melasma and, possibly, lentigo maligna. In addition, azelaic acid has an antiproliferative and cytotoxic effect on the human malignant melanocyte, and preliminary findings indicate that it may arrest the progression of cutaneous malignant melanoma. The mechanism of this selective cytotoxic action of azelaic acid is unclear, but may possibly be related to its inhibition of mitochondrial oxidoreductase activity and DNA synthesis. In controlled studies, topical azelaic acid demonstrated comparable anti-acne efficacy to topical tretinoin, benzoyl peroxide, erythromycin and oral tetracycline, while in patients with melasma azelaic acid proved at least as effective as topical hydroquinone. On topical application azelaic acid is well tolerated, with adverse effects apparently limited to a generally mild and transient local cutaneous irritation. Thus, topical azelaic acid, employed either as monotherapy or in combination with other treatments, is likely to prove of value in the management of acne and several hyperpigmentary disorders, most notably melasma.
We describe two simple, reproducible scoring systems for assessing acne severity, and we emphasize the technical problems which could invalidate either technique. Constant baseline data is desirable for any clinical trial, and our data clearly show that acne patients should ideally be off all treatment for at least 2 months before the start of a therapeutic trial.
Follicular concentrations of azelaic acid (AzA) were determined in vivo using a rapid, non-invasive method, after a single topical application of 20% (w/w) AzA cream, in order to establish whether the in vitro antimicrobial effects observed in previous studies are relevant in vivo. Preweighed amounts of 20% (w/w) AzA cream were applied over demarcated areas on the forehead and back of nine young adults, and samples were taken over a period of 5 h. AzA was removed from the skin surface by washing with acetone, and follicular casts were collected using cyanacrylate gel. The samples were centrifuged to remove particulate matter, and the supernatants derivatized for analysis by HPLC. Although the results showed wide-ranging variability, the follicular concentration increased as the amount present on the surface declined. The maximum follicular concentrations of AzA attained ranged from 7.5 to 52.5 ng (micrograms of follicular casts)-1 and 0.5 to 23.4 ng (micrograms of follicular casts)-1 in samples taken from the back and forehead, respectively. Assuming an average density of follicular material of 0.9 g ml-1, the mean maximum follicular concentration attained on the back was between 36 and 251 mmol/l, and on the forehead was between 2 and 112 mmol/l, and indicates that the concentration of AzA attained in follicular casts after a single topical application is comparable with the concentration required to inhibit the growth of Propionibacterium acnes and Staphylococcus epidermidis, in vitro.
Azelaic acid cream (20 percent) is a new topical treatment for acne with an additional therapeutic potential in rosacea and hyperpigmentation disorders. Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. Comparisons with clinically proven therapies have shown that 20 percent AzA cream is an effective monotherapy in mild to moderate forms of acne, with an overall efficacy comparable to that of tretinoin (0.05 percent), benzoyl peroxide (5 percent), and topical erythromycin (2 percent). In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes.
Successful management of acne requires careful patient evaluation followed by consideration of several patient and medication factors when selecting a particular therapeutic regimen. Within the last few years, several new agents for the treatment of acne have become available that afford greater flexibility in the treatment of this prevalent dermatologic disorder. These include adapalene, tazarotene, 2 new topical tretinoin formulations, azelaic acid, a new sodium sulfacetamide formulation, and an oral contraceptive recently approved by the Food and Drug Administration for the treatment of acne. After a brief overview of the pathophysiology of acne and existing therapies, this review evaluates the new antiacne agents and how they can be integrated into a successful treatment strategy that takes into account acne severity and predominant lesion type as well as age, skin type, lifestyle, motivation, and the presence of coexisting conditions.
Acne vulgaris is a common skin disease, affecting about 70-80% of adolescents and young adults. It is a multifactorial disease of the pilosebaceous unit.(1) The influence of androgens at the onset of adolescence leads to an enlargement of the sebaceous gland and a rise in sebum production. Additional increased proliferation and altered differentiation of the follicular epithelium eventually blocks the pilosebaceous duct, leading to development of the microcomedo as the primary acne lesion. Concomitantly and subsequently, colonization with Propionibacterium acnes increases, followed by induction of inflammatory reactions from bacteria, ductal corneocytes, and sebaceous proinflammatory agents (Fig 1).(2-5)
Azelaic acid (AzA) is a naturally occurring dicarboxylic acid that has a long and complex history in the treatment of skin disorders. We summarize research on AzA from the past 25 years and follow its progress from a treatment of hyperpigmentation to a therapy for acne vulgaris and inflammatory (papulopustular) rosacea.
Twenty percent azelaic acid gel is recommended as a topical treatment for acne due to its favorable profile.
Our objective in this study was to evaluate the efficacy of 20% azelaic acid gel in the treatment of mild to moderate acne vulgaris.
This was a double blind, randomized clinical trial. Sixty patients with mild to moderate acne vulgaris were selected randomly to receive either azelaic acid gel or the vehicle gel alone. Patients were followed up every 15 days for a period of 45 days. The number of lesions and the acne severity index (ASI) were recorded and compared using Student's t-test.
Total lesion count was reduced by 60.6% and 19.9% by azelaic acid gel and the placebo respectively (P = 0.002). ASI was reduced by 65.2% and 21.3% by azelaic acid gel and the placebo respectively (P = 0.001), i.e, azelaic acid gel was 3.06 times more effective than the placebo in reducing ASI.
Azelaic acid gel can be used as an effective treatment in mild to moderate acne vulgaris.
In December of 2002, the FDA approved azelaic acid 15% gel for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid is a saturated dicarboxylic acid, which is naturally occurring and has been used in the treatment of rosacea, acne, and melasma. The 15% gel has a high efficacy and is generally well tolerated, with the local irritation (burning, stinging, itching, and scaling) being typically mild and transient. Azelaic acid 15% gel is considered effective and safe as a therapy for inflammatory papulo-pustular rosacea and is suitable for use on all skin types.
Azelaic acid (AzA) 15% gel is approved for the treatment of rosacea in the US, but also has approval for the treatment of acne vulgaris in many European countries where it has demonstrated success. Two randomized, multicenter, controlled clinical trials compared the effects of AzA 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all using a twice-daily dosing regimen. The primary endpoint in the intent-to-treat analysis was a reduction in inflammatory papules and pustules. AzA 15% gel resulted in a 70% to 71% median reduction of facial papules and pustules compared with a 77% reduction with benzoyl peroxide 5% gel and a 63% reduction with clindamycin. AzA 15% gel was well-tolerated. In addition, a 1-year European observational study conducted by dermatologists in private practice evaluated the safety and efficacy of AzA 15% gel used as monotherapy or in combination with other agents in more than 1200 patients with acne. Most physicians (81.9%) described an improvement in patients' symptoms after an average of 34.6 days, and 93.9% of physicians reported patient improvement after an average of 73.1 days. Both physicians and patients assessed AzA 15% gel to be effective with 74% of patients being "very satisfied" at the end of therapy. AzA 15% gel was considered "well-tolerated" or "very well-tolerated" by 95.7% of patients. The majority of patients were more satisfied with AzA than with previous therapies. AzA 15% gel represents a new therapeutic option for the treatment of acne vulgaris.