Journal of the European Academy of Dermatology and Venereology

Published by Wiley

Online ISSN: 1468-3083


Print ISSN: 0926-9959


Two therapeutic challenges: Facial vitiligo successfully treated with 1% pimecrolimus cream and 0.005% calcipotriol cream
  • Article

April 2008


145 Reads

D B Bilaç


A T Ermertcan



S Oztürkcan

Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5-fluorouracil cream for the treatment of facial actinic keratosis: A prospective randomized trial

February 2015


74 Reads

Five per cent 5-fluorouracil (5-FU) cream is a well-established treatment for actinic keratosis (AK), and ingenol mebutate gel (IMB) is a novel topical field-directed therapy. To compare the tolerability and safety of IMB with that of 5-FU for the treatment of facial AK. An open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within a 25-cm(2) contiguous field on the face was conducted. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for 4 weeks. The treatment effect and the adverse events were evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43 for intent-to-treat populations. The mean (±SD) maximum local skin reactions (LSR) for patients treated with IMB was 10.85 (± 3.12), compared with 10.86 (± 3.55) for those who received 5-FU. Patients in the IMB group presented LSR that peaked at day 4 and almost completely regressed after 15 days. Differently, in the 5-FU group, the LSR peaked at day 29 and lasted until visit 36. Additionally, the area under the curve (LSR × visit) was significantly smaller for IMB. No differences between the treatments for pruritus, pain, tearing, conjunctival hyperaemia or headaches were noted, but the eyelid oedema rate was higher for IMB group. No significant difference in the proportion of dropouts was observed between groups. Both treatments demonstrated a suitable safety profile. For treating AKs, the local skin reactions in the IMB group were more short-lived compared with those of 5-FU, but both treatments seemed to be safe and tolerable. © 2015 European Academy of Dermatology and Venereology.

A comparison of adapalene gel 0.1% vs. tretinoin gel 0.025% in the treatment of acne vulgaris in China

February 2001


5,482 Reads

P Tu


G-Q Li


X-J Zhu




To compare the efficacy, safety and tolerability of adapalene gel 0.1% vs. tretinoingel 0.025% in a Chinese patient population. Although acne vulgaris is a common problem among Asians and Asian-Americans, little has been published on the specific manifestations, sequelae, and treatment-responsiveness of this disorder in Asian skin types. Since Asian skin types tend to be more highly pigmented than those of white people of European descent, many Asians share the predisposition toward postinflammatory hyperpigmentation seen in Africans, African-Americans and other dark-skinned peoples. It is generally assumed that the efficacy and safety of topical retinoids is the same in Asians as in white people. Tretinoin has been available in China for decades; adapalene became available in 1998. A total of 150 patients with grade II-III acne vulgaris seen at three dermatology clinics were randomized to 8 weeks of daily treatment with either adapalene gel 0.1% or tretinoin gel 0.025%. Counts of total lesions, inflammatory lesions and non-inflammatory lesions were made at baseline and again at treatment weeks 2, 4, 6 and 8. Global assessment ratings, based on percent lesion reduction from baseline were also made. Erythema, burning, pruritus, scaling and dryness were rated on a 0-3 severity scale. A total of 139 patients completed the efficacy evaluation, and 144 patients completed the safety evaluation. Both adapalene and tretinoin produce dramatic reductions in total, inflammatory and non-inflammatory lesion counts, in the range of 69-74% on average. More than 70% of patients in both groups had complete clearance or marked improvement. In general, irritation was mild, but was both more common and more severe in the tretinoin group vs. the adapalene group. No systemic side effects were seen. Adapalene offers comparable efficacy to tretinoin, but is less irritating. It represents a good alternative for the treatment of mild to moderate acne vulgaris in Chinese patients.

Efficacy of the fixed 1.2% clindamycin phosphate, 0.025% tretinoin gel formulation (Velac (R)) and a proprietary 0.025% tretinoin gel formulation (Aberela (R)) in the topical control of facial acne

December 1998


69 Reads

Background: A formulation containing agents affecting the non-inflammatory as well as the inflammatory lesions of acne vulgaris at the same time would be efficient, probably showing a high efficacy and possibly a considerable shortening of the duration of treatment. One single formulation would simplify drug administration thereby enhancing patient compliance and possibly leading to improved therapeutic results. In two studies this seems to have been corroborated for the fixed clindamycin phosphate-tretinoin gel formulation. Objective: This study was designed to assess whether the recently developed fixed formulation of 1.2% clindamycin phosphate and 0.025% tretinoin in a gel base (Velac), further referred to as Clindamycin phosphate Tretinoin Gel is at least as effective as a proprietary 0.025% tretinoin gel formulation (Aberela, Janssen Cilag Ab, Sollentuna, Sweden; further defined as tretinoin) showing an additional anti-inflammatory effect in the treatment of moderate to severe acne vulgaris. Methods: In a double-blind, randomised study 72 patients were treated with CTG and 73 with tretinoin gel in a once daily regimen for 12 weeks. Responses, irritation as well as possible systemic and other adverse effects were recorded after 4, 8 and 12 weeks of treatment and the improvement, compared to baseline, assessed in all included patients. An additional assessment of the safety parameters was carried out at week 2. Parameters of efficacy were the various acne lesion counts, the overall acne severity grade and the calculated totals of acne lesion counts. Results: CTG was statistically significantly more effective than tretinoin at the P = 0.05 level in the papular and the total mean inflammatory lesion counts as well as in the estimated or calculated mean overall acne severity scores. CTG and tretinoin gel were equally effective in the remaining parameters: open and closed comedones, the calculated total mean comedone, the pustule as well as the nodule lesion counts. The onset of action was faster for CTG than for tretinoin gel and evident in all assessed parameters except in open comedone lesion counts. In the calculated total mean acne lesion counts, half of all acne lesions had disappeared by week 6 of treatment with CTG, whereas this was recorded at week 9 for tretinoin gel. No clinically relevant changes in the parameters of safety as a consequence of treatment were observed, although the burning component of irritation was shown to be significantly less for CTG than for tretinoin gel. The observed adverse effects were considered minor. Treatment had to be discontinued in five patients on CTG and three on tretinoin. Conclusion: The addition of clindamycin to tretinoin, as in CTG, enhances the comedolytic efficacy of tretinoin in moderate to severe acne of the face, maintaining at the same time its anti-inflammatory efficacy thus accelerating resolution of all types of acne lesions without affecting the safety of response to both components.

Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: Clinical efficacy and economic impact over 12 months

February 2010


72 Reads

Rational healthcare decision-making based on clinical and economic evidence is essential to provide the best possible care for patients with atopic dermatitis (AD). To evaluate treatment outcomes, resource use and cost associated with twice-weekly tacrolimus 0.03% ointment treatment vs. standard flare-only therapy in children with moderate-to-severe AD. In a pan-European, Phase III multicentre randomized clinical trial, children with mild-to-severe AD were randomized to 0.03% tacrolimus ointment or vehicle twice weekly for 12 months. Disease flares were treated using open-label tacrolimus 0.03% ointment twice daily. Clinical efficacy data were evaluated in a subgroup of 153 children with moderate-to-severe AD, with resource use data--collected prospectively using caregiver questionnaires--available from 146 children. Pooled costs of resource use were determined using German unit cost data. Direct and indirect costs were considered from third-party payer, patient and caregiver, and societal perspectives. Twice-weekly tacrolimus ointment reduced the number of flares compared with standard therapy (P < 0.001) and prolonged time to first flare (146 vs. 17 days, P < 0.001). Mean +/- SD annual costs per patient for standard and twice-weekly therapy respectively were 2002 euro +/- 2315 vs. 1571 euro+/- 1122 for severe AD and 1136 euro +/- 1494 vs. 1233 euro +/- 1507 for moderate AD. In children with AD, twice-weekly treatment with tacrolimus 0.03% ointment reduces the number of flares and prolongs time spent free from flares with no additional cost in children with moderate AD, and may be cost-saving in those with severe AD.

The efficacy of '0.05% Clobetasol + 2.5% zinc sulphate' cream vs. '0.05% Clobetasol alone' cream in the treatment of the chronic hand eczema: A double-blind study

June 2008


484 Reads

Many therapeutic modalities have been suggested for treatment of the chronic hand eczema. Despite good immediate efficacy of some of these treatments, there is high recurrence of the dermatitis following cessation of the treatment. Regarding the beneficial effects of the zinc sulfate on the skin, we designed a double blind study to evaluate the efficacy of the '0.05% Clobetasol + 2.5% zinc sulphate' cream versus '0.05% Clobetasol alone' cream in the treatment of the chronic hand eczema. This study was a double-blind, right to left, prospective, clinical trial. In total, 47 patients with chronic hand eczema admitted to dermatology center of Isfahan University of Medical Sciences were selected and their right hand or left hand were selected at random to be treated with either the '0.05% Clobetasol + 2.5% zinc sulphate' cream or '0.05% Clobetasol alone' cream twice daily for 2 weeks. All of the patients were treated for 2 weeks and were followed up at weeks 2, 4, 6 and 8 after starting the treatment. For determining the severity of chronic hand eczema, we assessed and scored 4 different characteristics of the lesions including redness; scaling; lichenification and pruritus. The data were analyzed using SPSS program (release 13) and statistical tests including Mann-Whitney test. Overall, 47 patients (94 samples) were evaluated. All of these patients had similar and symmetrical lesions on their right and left hands. Out of them, 35 patients were females and 12 patients were male. In all of the evaluated characterisitics, the '0.05% Clobetasol + 2.5% zinc sulphate' cream was more effective than '0.05% Clobetasol alone' cream (P < 0.05). The recurrence rate of eczema was significantly lower in the group treated with this combination treatment (P < 0.05). With regard to the encouraging results of the combination treatment with Clobetasol + zinc sulphate, we suggest that in a more extensive clinical trial, the efficacy of this treatment against chronic hand dermatitis be evaluated. In addition, evaluation of this combination therapy against other inflammatory dermatosis seems to be logical.

Gene expression profiling in psoriatic scalp hair follicles: Clobetasol propionate shampoo 0.05% normalizes psoriasis disease markers

March 2010


64 Reads

Clobetasol propionate shampoo is effective and safe in treatment of scalp psoriasis (SP). Gene expression profiling of psoriatic skin biopsies led to the identification of numerous disease-related genes. However, it remained unknown whether the gene expression profile of hair follicles of SP patients was also affected. To determine whether psoriasis-related genes are differentially regulated in the hair follicles of SP patients and whether the modulation of these genes can be correlated with clinical severity scores. A single arm, open study was conducted in three centres. SP patients received daily treatment with clobetasol propionate shampoo. At Baseline, Weeks 2 and 4, investigators assessed clinical severity parameters and collected scalp hair follicles in anagen phase. Total RNA extracted from hair follicles was used to determine the expression level of 44 genes, which were reported previously to be upregulated in the skin of psoriasis patients. RNA of good quality and sufficient quantity was obtained from hair follicles of psoriasis patients and healthy volunteers (HV). The expression level of 10 inflammation-related genes was significantly increased in psoriatic hair follicles. The patient's exploratory transcriptomic score, defined as the mean fold modulation of these 10 genes compared with HV, correlated with clinical severity scores. Clobetasol propionate shampoo was effective in decreasing both the exploratory transcriptomics and the clinical severity scores. Hair follicles of SP patients are affected by the inflammatory process. The change in the expression level of inflammation-related genes correlates with the severity of the disease.

Treatment of scalp psoriasis with clobetasol-17 propionate 0.05% shampoo: A study on daily clinical practice

October 2009


40 Reads

Safety and clinical effectiveness of clobetasol-17 propionate 0.05% shampoo have been shown in patients with scalp psoriasis. First, to evaluate treatment satisfaction, user convenience safety and effectiveness of clobetasol-17 propionate 0.05% shampoo treatment in daily clinical practice. Second, to identify subgroup variables that may predict treatment success or failure. A total of 56 patients with scalp psoriasis were treated with short-contact clobetasol-17 propionate 0.05% shampoo once daily for 4 weeks. Data on treatment satisfaction, user convenience, safety and effectiveness were assessed on a 7-point Likert scale using postal questionnaires. Subgroup analyses were performed to identify variables that may predict treatment outcome. A total of 41 patients returned both questionnaires (73%). Positive treatment satisfaction and user convenience were reported by 66% and 79% of patients respectively. Patient-rated indicators for disease severity improved by 39-46% (P < 0.05%). No major side-effects were reported. Subgroup analyses did not reveal any statistically significant patient variable that may predict treatment outcome. However, a tendency towards improved treatment satisfaction was observed in patients who had received fewer topical antipsoriatic treatments previously (P > 0.05). Short-contact treatment with clobetasol-17 propionate 0.05% shampoo has high user convenience and patient satisfaction rates. Moreover, the treatment is well-tolerated and efficacious from patients' perspective. Subgroup analyses did not reveal factors predicting treatment outcome, although treatment success tended to be more evident in patients who had received fewer treatments previously.

Comparison of tretinoin 0.05% cream and 3% alcohol-based salicylic acid preparation in the treatment of acne vulgaris

March 2011


406 Reads

No single effective topical treatment is available for treating all pathogenic factors causing acne vulgaris (AV). Salicylic acid (SA), tretinoin (all-TRA) and clindamycin phosphate (CDP) are known to to be effective agents depending on their comedolytic and anti-inflammatory properties. To compare the efficacy and tolerability of SA and CDP combination (SA+CDP) with all-TRA and CDP (all-TRA+CDP) in patients with mild to moderate facial AV. Forty-six patients aged between 18 and 35 years were enrolled in a 12-week prospective, single-blind, randomized and comparative clinical study. Efficacy was assessed by lesion counts, global improvement, quality of life index and measurement of skin barrier functions. Local side effects were also evaluated. Both combinations were effective in reducing total lesion (TL), inflammatory lesion (IL) and non-inflammatory lesion (NIL) counts and showed significant global improvement as evaluated by the investigator. At the end of the study, there was no significant difference between the two groups in terms of all lesion counts. In addition, TL counts decreased faster in the all-TRA+CDP group compared with those in the SA+CDP group, with a significant difference between the two groups occurring as early as 2 weeks. Safety evaluations demonstrated that the incidence of mild to moderate side effects generally peaked at week 2 and declined gradually thereafter. Both combinations did not have an effect on stratum corneum hydration, although skin sebum values decreased with SA+CDP treatment. Combination of SA+CDP and all-TRA+CDP was effective in decreasing lesion counts and well tolerated with minimal local cutaneous reactions in patients with mild to moderate AV.

Figure 1: Corel Draw's grid used for objective assessment of repigmentation.
A double-blind, randomized trial of 0.05% betamethasone vs. topical catalase/dismutase superoxide in vitiligo
  • Article
  • Full-text available

June 2008


154 Reads

Among all the topical immunomodulators, vitiligo's mainstay therapy includes topical corticosteroids. Many other non-immune theories have also been suggested for vitiligo's pathogenesis, but the role of oxidative stress has gained more importance in recent years. To compare the effect of topical 0.05% betamethasone vs. catalase/dismutase superoxide (C/DSO). Randomized, matched-paired, double-blind trial. Dermatology Section, University of Antioquia, Medellín, Colombia. Patients (aged > 18 years or between 12 and 18 years) with parent's informed consent, with stable or active bilateral vitiligo. Topical 0.05% betamethasone or C/DSO. Two lesions similar to each other in size were chosen. All assessments were made by two blinded investigators, and photographs were subjected to morphometry analysis. Skin repigmentation by digital morphometry. Twenty-five patients were enrolled in the study (21 women and 4 men). Mean age of participants was 40 years (range: 12-74 years). One patient on C/DSO experienced a mild local erythematous papular rash that self-resolved. At 4 months of therapy, there was no statistical difference on the percentage of repigmentation between betamethasone and C/DSO (5.63% +/- 27.9 vs. 3.22% +/- 25.8, respectively, P = 0.758). After 10 months of therapy, the percentage of skin repigmentation increased to 18.5 +/- 93.14% with betamethasone and to 12.4 +/- 59% with C/DSO, but again, we found no statistical differences (P = 0.79). Few studies have described objective methods to evaluate repigmentation among vitiligo patients. Digital morphometry provides an objective assessment of repigmentation in vitiligo. Objective vitiligo repigmentation with topical C/DSO at 10 months is similar to topical 0.05% betamethasone. Although a mild adverse effect was related to the use of C/DSO, such finding was not severe enough to discontinue treatment.

Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: A randomized, double-blind placebo-controlled trial

December 2006


1,024 Reads

Background: Clinical efficacy of topical corticosteroids in alopecia areata (AA) is still controversial. Positive clinical results have been obtained using ointments with occlusive dressing but this approach has a low patient compliance. Recently, a new topical formulation (thermophobic foam: Versafoam) of clobetasol propionate 0.05% has been introduced on the market (Olux, Mipharm, Milan, Italy) (CF). This formulation is easy to apply. After application to the skin the foam quickly evaporates without residues and it has a good patient compliance. In vitro studies have also shown that this formulation enhances the delivery of the active compound through the skin. Aim: To evaluate the efficacy, safety and tolerability of CF in the treatment of moderate to severe AA. Subjects and methods: Thirty-four patients with moderate to severe AA (eight men, mean age 40+/-13 years) were enrolled in a randomized, double-blind, right-to-left, placebo-controlled, 24-week trial. Alopecia grading score (AGS) was calculated at baseline and after 12 and 24 weeks of treatment using a 0-5 score (0=no alopecia; 5=alopecia totalis). Clobetasol foam and the corresponding placebo foam (PF) were applied twice a day for 5 days/week for 12 weeks (phase 1) using an intrapatient design (right vs. left). From weeks 13 to 24 each enrolled patient continued only with the treatment (both on the right and left site) that was judged to have a greater efficacy than that on the contralateral side (phase 2). The primary outcome of the trial, evaluated on an intention-to-treat basis, was the hair regrowth rate, which was evaluated using a semiquantitative score (RGS) (from 0: no regrowth, to 4: regrowth of 75%). Results: At baseline the AGS was 4.1 (range: 2-5). Nine (26%) patients prematurely concluded the trial. At the end of phase 1, a greater hair regrowth was observed in 89% of the head sites treated with CF vs. 11% in the sites treated with PF. The RGS was 1.2+/-1.6 in the CF-treated sites and 0.4+/-0.8 in the PF-treated sites (P=0.001). A RGS of 2 (hair regrowth of more than 25%) was observed in 42% CF-treated sites and in 13% of PF-treated sites (P=0.027). In seven subjects (20%) a RGS of 3 to 4 (hair regrowth of 50%) was observed in CF-treated sites. In three subjects (9%) a RGS of 4 (hair regrowth of 75%) was observed in CF-treated sites. In one patient only, in a PF-treated region, a RGS of 3 was observed. The AS was reduced to 3.8 by CF treatment at the end of phase 1 and to 3.3 at the end of phase 2 (P=0.01). From weeks 12 to 24 the treatment with CF induced a further increase in the RGS (from 1.2 to 1.5+/-1.4). Forty-seven per cent of CF-treated patients had a RGS of 2 at the end of the trial. A total of eight patients (25%) at the end of the treatment with CF showed a RGS of 3. Folliculitis occurred in two patients. No significant modifications in cortisol and ACTH blood levels were observed during the trial. Conclusion: This new formulation of clobetasol propionate foam is an effective, safe and well-tolerated topical treatment for AA. This formulation has a good cosmetic acceptance and patient compliance profile.

Tacrolimus 0.1% ointment in nail psoriasis: A randomized controlled open-label study

July 2012


357 Reads

Background Despite recent advances in the treatment of psoriasis, the therapeutic options for nail psoriasis are very limited, particularly when this is the only manifestation of the disease. Objective We performed a randomized controlled open-label study to assess the efficacy and safety of a topical treatment with tacrolimus 0.1% ointment in nail psoriasis. Methods In each patient, tacrolimus 0.1% ointment was prescribed for application only on the affected nails of a randomly selected hand for 12 weeks, whereas nails of the other hand did not receive any treatment. Severity of nail psoriasis was evaluated using the Nail Psoriasis Severity Index (NAPSI) score. Results We enrolled 21 consecutive psoriatic patients. At week 12, a statistically significant (P < 0.001) improvement was obtained in the treated hands with respect to the hands used as control (NAPSI score absolute change 13.0 and 3.0 respectively). Each of the enrolled patients concluded the period of treatment, but one patient was withdrawn from tacrolimus application after 9 weeks because of the appearance of acute paronychia. Discussion Our study showed that tacrolimus 0.1% ointment may be an efficacious and safe therapeutic opportunity in the treatment of nail psoriasis. Our data should be confirmed by a double-blind study with a larger sample of patients.

Effective use of methylprednisolone aceponate 0.1% in a 9-month-old infant with atopic eczema and sleep disturbance

November 2012


59 Reads

A 9-month-old infant, with no family history of atopy, presenting with erythematous, itchy plaques, and sleep disturbance, was diagnosed with atopic eczema (AE). Previous treatment with topical hydrocortisone and emollients had little effect. The infant was treated nightly with methylprednisolone aceponate (MPA) 0.1% (Advantan(®) ) cream, in addition to emollients and an oral antihistamine. After 1 week of once-daily MPA 0.1% treatment, followed by 1 week of alternate-day treatment with Advantan, significant improvements in AE symptoms and sleep were observed. The patient's caregiver reported overall treatment satisfaction and no side effects of Advantan. For this infant with newly diagnosed AE, Advantan improved symptoms and sleep quality in a safe and well-tolerated manner.

Treatment of vitiligo with narrowband-UVB (TL01) combined with tacrolimus ointment (0.1%) vs. placebo ointment, a randomized right/left double-blind comparative study

April 2011


176 Reads

Only a few, small double-blind clinical trials have been reported for the treatment of vitiligo. Narrowband-ultraviolet B (NB-UVB) is an established form of treatment for this condition. Tacrolimus ointment is assumed to have an effect in some patients. To assess the additive effect of tacrolimus ointment (0.1%) once daily in vitiligo patients treated with NB-UVB. In a randomized double-blind trial, patients with stable symmetrical vitiligo were treated half-side with tacrolimus ointment (0.1%) and half-side with placebo ointment. Whole body NB-UVB was given twice or thrice weekly for at least 3 months. As a morphometric device, Visitrak(TM) was used to measure the area of the vitiligo target lesions. Of 40 patients, 27 had a better effect on the tacrolimus side. The degree of improvement was significantly better on the tacrolimus side (P = 0.005). The median reduction in the target lesion areas was 42.1% on the tacrolimus side and 29% on the placebo side. There was a correlation between the effect and the number of topical tacrolimus applications (P = 0.044), but there was no correlation with the number of UV treatments given; neither any significance of gender, age, skin type, duration of disease, familial occurrence of vitiligo nor presence of other autoimmune disease or atopy was observed. We found a significant reduction in the patients' subjective disease impact during the treatment period (P < 0.001). According to this study, the combination of NB-UVB and tacrolimus ointment (0.1%) is more effective than UV treatment alone in patients with vitiligo. The effect is tacrolimus total dose-dependent.

A prospective, randomized clinical trial comparing topical Aloe vera with 0.1% triamcinolone acetonide in mild to moderate plaque psoriasis

September 2009


621 Reads

Topical aloe vera (AV) has been used to treat various skin conditions, including psoriasis, with good results. This study aims to compare the efficacy of AV and 0.1% triamcinolone acetonide (TA) in mild to moderate plaque psoriasis. A randomized, comparative, double-blind, 8-week study was designed. Eighty patients randomly received AV or 0.1% TA cream and their clinical response were evaluated using the Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI). After 8 weeks of treatment, the mean PASI score decreased from 11.6 to 3.9 (-7.7) in the AV group and from 10.9 to 4.3 (-6.6) in the TA group. Between-group difference was 1.1 (95% confidence interval -2.13, -0.16, P = 0.0237). The mean DLQI score decreased from 8.6 to 2.5 (-6.1) in the AV group and from 8.1 to 2.3 (-5.8) in the TA group. Between-group difference was 0.3 (95% confidence interval -1.18, -0.64, P = 0.5497). There was no follow-up period after the 8-week treatment. AV cream may be more effective than 0.1% TA cream in reducing the clinical symptoms of psoriasis; however, both treatments have similar efficacy in improving the quality of life of patients with mild to moderate psoriasis.

Mometasone furoate 0.1% and salicylic acid 5% vs. mometasone furoate 0.1% as sequential local therapy in psoriasis vulgaris

April 2009


378 Reads

BACKGROUND AND OBJECTIV:E Treatment in psoriasis vulgaris continues to unmet needs in terms of efficacy, quality of life and costs. Patients with moderate forms of psoriasis are using topical corticosteroids as first-line therapy and patients with severe forms also use this therapy. Optimization of this treatment is made by the use of combination drugs or by the sequential or rotational therapies. A multicentric clinical study was performed to measure the efficiency of mometasone furoate 0.1% and salicylic acid 5% and mometasone furoate 0.1% as sequential local therapy in psoriasis. This was a randomized, multicentre trial with two patient groups receiving active treatment. The study group (N = 184) received mometasone furoate 0.1% and salicylic acid 5% for the first 7 days of treatment, and in the following 14 days, the patients used mometasone furoate 0.1%. The second group (N = 176) was treated with mometasone furoate 0.1% for 21 consecutive days. Psoriasis Area Severity Index (PASI) score and Dermatology Life Quality Index (DLQI) were calculated. After the first week of treatment in the study group, the reduction of PASI score was 44%, statistically significant greater than the reduction of PASI score in the second group (37%). Quality of life estimated by DLQI indicated significant lower values in the first (study) group. The sequential treatment mometasone furoate 0.1% and salicylic acid 5% followed by mometasone furoate 0.1% proves to be efficient, safe and an excellent option for the following sequence: in-patient and out-patient.

Tacrolimus ointment 0.1% in the treatment of allergic contact eyelid dermatitis

April 2009


109 Reads

Tacrolimus inhibits T-lymphocyte activation and dermal Langerhans' cells, without the side-effects of corticosteroids. The safety profile of tacrolimus makes it a promising therapeutic option for dermatitis affecting the delicate periorbital skin. To access the efficacy and tolerability of tacrolimus ointment 0.1% in the treatment of allergic contact eyelid dermatitis. Twenty adults (16 women, 4 men) with eyelid dermatitis and with at least one positive patch test reaction to relevant contact allergens were treated with topical tacrolimus in a prospective, open-label, non-comparative clinical study. Dermatitis was graded at baseline, at day 30 and day 60, using a 4-point grading system for the following parameters: erythema, oedema, scaling, lichenification, fissuring (investigator assessment) and burning/stinging and pruritus (patient assessment). All patients completed the study. Erythema, oedema, scaling and lichenification showed improvement from baseline to 30 days of treatment ( P < 0.001), but fissuring was not significantly affected. At 60 days, no further improvement of these investigator parameters was observed. Patient parameters improved significantly by day 30 ( P < 0.004) and there was a trend for further improvement at the end of 60 days (for burning, P = 0.046; for pruritus, P = 0.059). Ten per cent of patients mentioned burning and itching, at the application site, during the first days of treatment. No other adverse events were observed. Topical tacrolimus is a promising alternative in patients with allergic contact eyelid dermatitis. Therapy was effective by 1 month and was well tolerated. These preliminary results merit a larger, controlled, study.

Mometasone fuoroate 0.1% ointment in the treatment of vulvar lichen sclerosus: A study of efficacy and safety on a large cohort of patients

July 2013


117 Reads

Guidelines identify a 3-month topical application of an ultra-potent corticosteroid ointment as the mainstay of medical treatment for vulvar lichen sclerosus (VLS). However, there are no trials providing evidence that any specific corticosteroid is superior to another. To assess the effectiveness and safety of a 12-week application of mometasone furoate (MMF) 0.1% ointment, with a tapering regimen, in achieving control of VLS signs and symptoms and to detect potential risk factors for VLS non-response. 147 patients affected with VLS were enrolled in a 12-week active treatment phase (ATP) with topical 0.1% MMF. The primary efficacy endpoint was the rate of patients achieving clinical response, as defined by protocol parameters. The secondary efficacy endpoint was to assess the changes of mean VLS-related symptoms after the 12-week ATP compared with baseline. By the end of the ATP, 113 patients (80.7%) experienced a treatment response, whereas 27 women (19.3%) were judged as non-responders. Mean symptom scores decreased significantly in the study patients, regardless of their clinical response at the end of the ATP. Among all the epidemiological and clinical data considered, only the absence of previous medical therapies was found to be related to a significantly higher risk of non-response to treatment. Application of 0.1% MMF ointment for 12 weeks on a tapering regimen was found to be an effective and safe therapy option in the ATP of VLS and could represent an alternative first-line treatment to an ultra-potent molecule.

A new formulation of an occlusive dressing containing betamethasone valerate 0.1% in the treatment of mild to moderate psoriasis

March 2006


138 Reads

Betamethasone valerate (BMV) is a medium-potency corticosteroid commonly used for the treatment of chronic psoriasis. Although occlusion has been shown to enhance the efficacy of BMV treatment, no ready-to-use occlusive BMV formulation is currently approved for the market. Forty-two patients with mild to moderate psoriasis and with symmetrical lesions were treated with BMV 0.1% tape and BMV 0.12% cream for 30 days in a half-side distribution. Both treatments resulted in a significant clinical improvement. Efficacy and tolerability were evaluated by comparison of pre-treatment and post-treatment psoriasis area and severity index and self-administered psoriasis area and severity index scores, and by comparison of the changes from baseline in clinical appearance and hydration. Lesions treated with BMV 0.1% tape showed higher reductions from baseline in the psoriasis area and severity index and the self-administered psoriasis area and severity index scores (61.7% and 59.3%, respectively), compared with lesions treated with BMV 0.12% cream (39.5% and 34.0%, respectively). No serious local or systemic treatment-related adverse effects were reported. Our results indicate a higher efficacy of BMV 0.1% tape compared with BMV 0.12% cream in the treatment of mild to moderate chronic plaque psoriasis.

Methylprednisolone aceponate 0.1% in the treatment of pruritic lichenified eczema in a 3-year-old child with chronic atopic dermatitis

November 2012


107 Reads

A 3-year-old girl with a > 2-year history of atopic dermatitis (AD) and known egg allergy, presented with an extensive AD flare including exudative eczematous lesions and lichenification on her flexures. The patient reported intense pruritus and showed signs of scratching on her trunk, arms, buttocks and thighs. After 2 weeks of twice-daily application of methylprednisolone aceponate (MPA) 0.1% (Advantan(®) ), temporary withdrawal of emollients, and mild bathing/cleanser use, the eczematic condition was considered clear, and marked improvement of all treated lesions (including disappearance of scaling) were observed. No side effects of Advantan were reported; the patient's parents expressed a high level of satisfaction with treatment. Advantan was safe and effective in controlling a severe pruritic flare of chronic AD in a small child.

Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%

August 2007


1,176 Reads

Microcomedones representing the clinically non-visible central precursor lesions of acne are induced by sebaceous hyperplasia as well as altered follicular growth and differentiation, and evolve into both comedones and inflammatory lesions. Thus, targeting microcomedone formation is essential in the prevention and therapeutic control of acne. The aim of this study was to assess the capacity of adapalene gel, 0.1%, to control the number of microcomedones after a combination treatment followed by a maintenance treatment. This was a single-site exploratory study in subjects with a diagnosis of mild to moderate acne vulgaris and the presence of at least 250 microcomedones per cm(2) at screening visit, counted via cyanoacrylate strips (CyASt). During the first 8 weeks, a combination of adapalene gel (0.1%) and benzoyl peroxide gel (2.5%) was applied. During the randomized, investigator-blinded, and vehicle-controlled 12-week maintenance phase, adapalene once daily (QD), or adapalene alternately with its vehicle once daily every other day (QoD), or vehicle QD were applied to the face. CyASt sampling on the forehead was done at baseline, week 8, and week 20. Lesion counting allowing calculating a defined success rate was done at all visits. A total of 54 subjects entered the combination phase, and 49 subjects were randomized into the maintenance phase: 16 in both the adapalene QD and the QoD group and 17 subjects receiving the vehicle. The microcomedone median count decreased for all groups until week 8 (end of combination phase) from 319 to 157. Microcomedone counts at the end of the maintenance phase (week 20) showed a significant percent difference (P = 0.04) between adapalene QoD (-53.5) and the vehicle (-42.1) and between adapalene QD (-50.6) and the vehicle (P = 0.037) compared with baseline. The application of adapalene gel, 0.1% monotherapy daily, or alternately every other day, significantly helps to control the microcomedone count during a 12-week maintenance treatment after a previous combination therapy with benzoyl peroxide in patients with mild to moderate acne.

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