Comparison of adapalene 0·1% solution and tretinoin 0·025% gel in the topical treatment of acne vulgaris

A multicentre study was conducted to compare clinical safety and efficacy of adapalene 0·1% solution and tretinoin 0·025% gel, both topical treatments for acne, in a once-daily dosage regimen for 12 weeks. A total of 297 patients were enrolled by eight investigators in this randomized, investigator-masked study in a parallel group design. An open label period using adapalene followed this study to assess the long-term safety of adapalene solution.
  Adapalene and tretinoin proved to be clinically and statistically effective in treating acne by reducing inflammatory (47% and 50%, respectively) and non-inflammatory lesions (57% and 54%) as compared to baseline. When comparing patients who had 75% or greater improvement in open comedones, adapalene was shown to be significantly more effective than tretinoin. No serious adverse event was reported during this study, including during the long-term period. The reactions that occurred were similar between treatments, i.e. burning, pruritus, scaling, dryness and erythema.     

A comparison of the efficacy and tolerability of adapalene 0·1% gel versus tretinoin 0·025% gel in patients with acne vulgaris: a meta-analysis of five randomized trials

The purpose of this meta-analysis was to determine if adapalene 0·1% gel (Differin®) provided superior efficacy and better tolerability than tretinoin 0·025% gel in the treatment of acne vulgaris. All comparative studies, both published and unpublished, from the United States and Europe, that fulfilled rigorous protocol criteria (multicentre, randomized, investigator-blind) were used. Five comparative studies met these criteria. In total, the meta-analysis evaluated 900 patients (450 treated with adapalene 0·1% gel, 450 treated with tretinoin 0·025% gel) with mild-to-moderate acne from the combined clinical trials. To avoid study bias, the meta-analysis used an intention-to-treat analysis. Statistical methodology for the meta-analysis included analysis of covariance, analysis of variance and Cochran–Mantel–Haenszel test. All statistical tests were two-sided, with the 0·05 probability level used to establish statistical significance, and 95% confidence intervals used to assess equivalence. Adapalene demonstrated equivalent efficacy to tretinoin in terms of reducing total lesion count. Adapalene demonstrated more rapid efficacy, as evidenced by a significant difference in the reduction of inflammatory and total lesions at week 1. Adapalene also demonstrated considerably greater local tolerability at all evaluation periods. The findings from this meta-analysis suggest that adapalene 0·1% gel constitutes a pharmacologic advance over such classic retinoids as tretinoin for the treatment of acne vulgaris.     

Adapalene 0·1% gel for the treatment of acne vulgaris: its superiority compared to tretinoin 0·025% cream in skin tolerance and patient preference

One hundred patients with acne vulgaris applied adapalene (Differin®) 0·1% gel to one side of their face and tretinoin 0·025% cream to the other once a day for 4 weeks; the side of application was determined by randomization code. Patient tolerance (assessed as the side of the face least irritated by drug application) was recorded weekly and patient preference (assessed as the preparation more easily spread, absorbed more quickly, smelled better, felt best on the skin and least greasy to the feel) at completion of the study. The investigator measured skin irritation weekly, scoring erythema, skin dryness, desquamation and burning/stinging on a 10-point scale.
  After each week of treatment, 64–68% of patients found adapalene 0·1% gel more tolerable than tretinoin 0·025% cream ( P < 0·05). At study completion, 65% of patients preferred adapalene 0·1% gel over tretinoin 0·025% cream ( P  = 0·003). An overall assessment showed adapalene 0·1% gel was significantly less irritating to the skin in terms of producing erythema, dryness, desquamation and burning/stinging, at Visits 2, 3 and 4 ( P < 0·02).
  Thirty-two patients experienced mild to moderately severe adverse events; three had adverse events considered to be drug related (two with skin discomfort; one with skin dryness). One patient stopped using the study drugs because of dry skin.
  This study showed that a majority of patients preferred adapalene 0·1% gel over tretinoin 0·025% cream and that it caused significantly less skin irritation.     

复方维A酸凝胶治疗寻常痤疮疗效和安全性评价

目的评价复方维A酸凝胶治疗寻常痤疮的疗效和安全性。方法采用多中心、随机双盲、平行对照临床试验,并与0.025%维A酸乳膏进行对照,每晚外用药物1次,疗程8周,治疗前及治疗后每2周分别对丘疹、脓疱和粉刺计数,进行疗效判断。结果进入临床研究240例,可进行疗效和安全性评价236例。对炎性损害(丘疹和脓疱)试验组在2周时的有效率为18.6%,4周时为41.5%,6周时为64.4%,8周时为82.2%;对照组分别为21.2%、44.9%、69.5%和79.7%,两组比较差异均无统计学意义。对非炎性损害(白头和黑头粉刺)试验组分别为5.3%、19.5%、43.4%和59.3%;对照组分别5.5%、24.6%、50.9%和66.4%,两组比较差异均无统计学意义。用药后局部皮肤反应发生率试验组为64.1%,对照组为32.2%,其中试验组有1例患者发生中重度反应(0.9%),因此而停药,两组比较差异具有统计学意义。结论复方维A酸凝胶治疗寻常痤疮与0.025%维A酸乳膏疗效相似,但局部皮肤不良反应高于后者。     

Comparative tolerance of adapalene 0·1% gel and six different tretinoin formulations

Adapalene 0·1% gel (Differin® gel) is a recently introduced topical treatment for mild to moderate acne which has been demonstrated to be much better tolerated and at least as effective as tretinoin 0·025% gel. We compared the tolerance of adapalene 0·1% gel with six different formulations and concentrations of tretinoin. A total of 55 healthy human subjects were enrolled in two controlled, randomized, observer blinded, intraindividual comparison studies. In the first study, adapalene 0·1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0·025%, 0·05% and 0·1% cream, tretinoin 0·01% and 0·025% gel, and petrolatum (control). In the second study, adapalene 0·1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0·025%, 0·05% and 0·1% cream, tretinoin 0·1% gel microsphere, and petrolatum (control). In both studies, cumulative irritation scores helped to define three groups of common irritancy potential, with significant differences between each group. In study A, the three groups were in descending order of irritancy: tretinoin 0·1% cream and tretinoin 0·05% cream; tretinoin 0·025% gel, tretinoin 0·01% gel and tretinoin 0·025% cream; adapalene 0·1% gel and petrolatum (control). In study B, the three groups were in descending order of irritancy: tretinoin 0·1% cream; tretinoin 0·05% cream, tretinoin 0·025% cream and tretinoin 0·1% gel microsphere; adapalene 0·1% gel and petrolatum (control). The experimental results show that adapalene 0·1% gel is significantly better tolerated than any of six formulations of tretinoin, including two gels, three creams and a microsphere formulation, ranging in potency from 0·01% to 0·1%.     

Randomised,controlled trial of the efficacy and safety of adapalene gel 0.1% and tretinoin cream 0.05% in patients with acne vulgaris

BACKGROUND: Previous clinical trials have shown that adapalene gel produces less irritation than tretinoin gels and tretinoin 0.025% cream. Short term results have shown that adapalene is less irritating than tretinoin gels and creams. This study is the first to compare the 0.1% formulation of adapalene gel with the 0.05% strength of tretinoin cream in a formal clinical trial. OBJECTIVE: To investigate the efficacy and tolerability of adapalene gel 0.1% compared with tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris. METHODS: Ten-week, multicentre, randomised, investigator-masked, active-controlled, parallel group study in 409 patients with acne vulgaris. RESULTS: Adapalene gel 0.1% demonstrated equivalent efficacy in reduction of acne lesion counts and global improvement of acne severity over 10 weeks' treatment and was significantly better tolerated than tretinoin cream 0.05% in terms of erythema, dryness, desquamation and stinging/burning. CONCLUSION: Adapalene gel 0.1% showed equivalent efficacy and was significantly better tolerated than tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris.     

The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris: A randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle

A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3% versus adapalene gel 0.1% and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85% of subjects completed the study. Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% in total and noninflammatory lesion counts and in global severity score (P < .05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3% group relative to the vehicle group (P < .001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3% was superior to adapalene gel 0.1% and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1% gel.     

Clinical and bacteriological evaluation of adapalene 0.1% gel plus nadifloxacin 1% cream versus adapalene 0.1% gel in patients with acne vulgaris

This multicenter, randomized parallel group study investigated the efficacy and tolerability of adapalene 0.1% gel plus nadifloxacin 1% cream (combination therapy) compared with adapalene gel (monotherapy) during 12‐week treatment of acne vulgaris. A total of 184 Japanese patients aged above 12 years with moderate to severe acne as indicated by the Japanese severity grading criteria were randomized to combination therapy (n = 84) and monotherapy (n = 100) groups, both having comparable demographic and baseline characteristics. Adapalene was applied only to inflammatory acne lesions in order to minimize skin irritation and ensure the treatment results. Efficacy and safety evaluations, treatment compliance and satisfaction with drug application were periodically monitored. The combination therapy provided a significantly greater efficacy than adapalene in decrement of inflammatory papulopustular lesions at 4 weeks and thereafter (P = 0.0056). The overall judgment of the therapeutic efficacy by the physician at the end of study revealed a significant difference (P = 0.02496) between the groups in favor of combination therapy. Dryness was reported in a greater proportion of patients undergoing monotherapy than combination therapy at weeks 2 and 4 (P = 0.04652). The patient self‐assessment in satisfaction with the drug application at the end of study revealed a significant difference (P = 0.00268) between the groups in favor of combination therapy. Among 76 strains of Propionibacterium acnes isolated from 87 patients, no strain was resistant to nadifloxacin. Thus, the simultaneous use of adapalene and nadifloxacin may provide an additive and complementary effect, resulting in clinical superiority and greater patient adherence compared to adapalene monotherapy.     

Topical adapalene gel 0.1% vs. isotretinoin gel 0.05% in the treatment of acne vulgaris: a randomized open-label clinical trial

BACKGROUND: Topical application of isotretinoin and adapalene has proved effective in treating acne vulgaris. Both drugs demonstrate therapeutic advantages and less irritancy over tretinoin, the most widely used treatment for acne. They both act as retinoid agonists, but differ in their affinity profile for nuclear and cytosolic retinoic acid receptors. OBJECTIVE: To compare the efficacy and tolerability of adapalene gel 0.1% and isotretinoin gel 0.05% in the treatment of acne vulgaris of the face, in a randomized open-label clinical trial. METHODS: Eighty patients were enrolled and were instructed to apply adapalene gel 0.1% or isotretinoin gel 0.05% once daily over a 12-week treatment period. Efficacy determination included noninflammatory and inflammatory lesion counts by the investigator and global evaluation of improvement. Cutaneous tolerance was assessed by determining erythema, scaling and burning with pruritus. RESULTS: Adapalene and isotretinoin gels were highly effective in treating facial acne. Adapalene gel produced greater reductions in noninflammatory and inflammatory lesion counts than did isotretinoin gel, but differences between treatments were not statistically significant. Adapalene gel was significantly better tolerated than isotretinoin gel during the whole treatment period. CONCLUSIONS: The two gels studied demonstrated comparable efficacy. When adapalene and isotretinoin were compared, significantly lower skin irritation was noted with adapalene, indicating that adapalene may begin a new era of treatment with low-irritant retinoids.     

Comparable efficacy of adapalene 0.3% gel and tretinoin 0.05% cream as treatment for cutaneous photoaging

Background

Adapalene has been previously evaluated as a treatment for actinic keratosis (AK) and solar lentigines and shown to improve signs of photoaging.

Objectives

To evaluate whether adapalene 0.3% gel is non-inferior to tretinoin 0.05% cream as treatment for photoaged skin.

Materials & Methods

An investigator-blinded, parallel-group comparison study was conducted in Brazil. Subjects were randomised in a 1:1 ratio to receive, once daily, adapalene 0.3% gel or tretinoin 0.05% cream. Subjects were evaluated at Weeks 1, 4, 8, 12, 16, 20 and 24, based on clinical signs of cutaneous photoaging, histopathological and digital morphometric findings, as well as safety and tolerability.

Results

A comparison of clinical efficacy showed that both treatments did not differ significantly regarding clinical evaluation of the following criteria: global cutaneous photoaging, periorbital wrinkles, ephelides/melanosis, forehead wrinkles, and AK.

Conclusion

Adapalene 0.3% gel showed non-inferior efficacy to tretinoin 0.05% cream as treatment for photoaged skin, with a similar safety profile. Adapalene 0.3% gel may therefore be considered a safe and effective option for the treatment of mild or moderate photoaging.

     

Compared efficacy and safety of tretinoin 0.1% microsphere gel alone and in combination with benzoyl peroxide 6% cleanser for the treatment of acne vulgaris

Our purpose was to evaluate the efficacy and safety of a combination of benzoyl peroxide 6% cleanser and tretinoin 0.1% microsphere gel versus monotherapy with tretinoin 0.1% microsphere gel. Eighty-seven healthy males and nonpregnant nonlactating females between the ages of 12 and 30 years with moderate inflammatory acne vulgaris were enrolled in this randomized controlled, investigator-blind, parallel group clinical trial. Subjects were evaluated over 12 weeks for a total of 4 visits. The investigators and subjects completed questionnaires about the test medications. Data from the 56 subjects completing the protocol were considered in the analyses of efficacy and tolerability. The reduction in inflammatory lesions from baseline was significant for both treatment groups at the end of the study. However, there was a significantly greater reduction in the group receiving the combination regimen. Both treatment groups had significant reductions from baseline in noninflammatory lesions at week 12, but no differences were observed between treatment groups. With the exception of skin tightness, which was significantly greater at week 12 in the subjects who received the monotherapy, there were no significant differences between the 2 treatment groups with respect to localized irritation. Adverse events were rare in all subjects. Not only did the combination regimen result in a greater reduction of inflammatory acne lesions than use of the monotherapy but also it did not result in an increase in local irritation.     

Clinical efficacy of Velac®, a new tretinoin and clindamycin phosphate gel in acne vulgaris

Velac®, a new gel formulation containing both tretinoin (0.025%) and clindamycin phosphate (1.2%), is effective in acne vulgaris using a once daily application. The single formulation enhances compliance in young patients and improves the therapeutic results. Treatment with Velac was found to be more effective than tretinoin alone in inflamed lesions and at least comparable in open and closed comedones. In two of the three studies the overall acne severity grade was significantly more reduced when compared with tretinoin. Velac is also more effective than clindamycin alone in the treatment of the non-inflamed lesions. In the two multicentre studies the reduction of the overall acne severity grade was also more favourable for the new gel formulation. A more rapid response occurred with Velac than with either component used (clindamycin or tretinoin) alone.     

Daily treatment with adapalene gel 0.1% maintains initial improvement of acne vulgaris previously treated with oral lymecycline

Topical retinoids are often recommended for preventing acne recurrence, but there are relatively few well-controlled maintenance studies published. The objective of the present study was to assess the maintenance effect of adapalene gel 0.1% relative to gel vehicle in subjects successfully treated in a previous 12-week adapalene-lymecycline 300 mg combination therapy study. This was a multicentre, investigator-blind, randomised, controlled study in 19 European centres. A total of 136 subjects with moderate to moderately-severe acne vulgaris who showed at least moderate improvement from baseline when treated with either adapalene plus lymecycline or lymecycline plus gel vehicle in a previous 12 week study were included. Subjects were randomised to receive adapalene gel 0.1% or vehicle once-daily for 12 weeks. Efficacy and safety criteria included maintenance rate, percent reduction in lesion counts (total, inflammatory, non inflammatory), global severity assessment, cutaneous tolerability, and adverse events. Adapalene provided better results relative to gel vehicle for all efficacy assessments. The maintenance rate for total lesions was 84.7% vs. 63.5% (P = 0.0049) with adapalene and the vehicle, respectively. Adapalene was safe and well tolerated in this study. This study demonstrates a clinical benefit of continued treatment with adapalene gel 0.1% as a maintenance therapy for acne.     

Single-blind and comparative clinical study of the efficacy and safety of benzoyl peroxide 4% gel (BID) and adapalene 0.1% Gel (QD) in the treatment of acne vulgaris for 11 weeks

objectives: To compare the efficacy and tolerability of a gel containing benzoyl peroxide 4%, used twice daily, with a gel containing adapalene 0.1% used once daily, in the treatment of acne vulgaris for 11 weeks. methods: 178 patients bearing acne vulgaris, aged between 13 and 30 years, were studied in a comparative and single-blind clinical study. The 178 patients were divided into two groups: 89 patients treated with benzoyl peroxide 4% and 89 patients treated with adapalene 0.1%. The treatment duration was 11 weeks. The efficacy assessment was conducted through an accounting of both the inflammatory and non-inflammatory lesions in all visits. The safety assessment was conducted through reports regarding adverse reactions and local tolerance in all visits and an overall tolerance at the end of the study. conclusions: The results showed that both treatments were efficient in the reduction of acne lesions after 11 weeks treatment and were well tolerated, without any serious adverse event report. The benzoyl peroxide 4% was superior in the reduction of the number of inflammatory and non-inflammatory lesions at weeks 2 and 5, when compared to adapalene 0.1%.     

0.1%阿达帕林凝胶和1%克林霉素溶液联合外用治疗寻常痤疮临床观察

目的:比较0.1%阿达帕林凝胶(达芙文)与1%克林霉素磷酸酯溶液(特丽仙)联合外用与特丽仙单用治疗寻常痤疮的疗效和安全性。方法:将300例中至重度寻常痤疮患者分为两组,试验组联合外用达芙文和特丽仙,对照组单用特丽仙,两组共治疗12周。结果:274例患者完成治疗,治疗4周后试验组皮损总数改善显著优于对照组(P<0.05),并维持至12周;治疗8周后试验组炎性皮损和非炎性皮损改善优于对照组(P<0.01),并维持至12周。治疗结束后试验组和对照组的有效率分别为84.40%和72.93%(P<0.05)。试验组局部刺激反应发生率为4.0%,对照组为8.7%。结论:达芙文联合特丽仙治疗中至重度寻常痤疮的疗效比单用特丽仙的效果好。     

Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents

Two 12-week, randomized, vehicle-controlled. double-blinded pivotal studies and a 12-month. long-term, open-label, noncomparative safety study were conducted to evaluate the efficacy and safety of dapsone gel 5% in patients with acne vulgaris. Of 3516 participants enrolled in the 3 trials, 1306 participants (37%) were adolescents aged 12 to 15 years and comprised the subgroup reported here. Participants randomly were assigned to twice-daily treatment with dapsone gel (n=578) or vehicle gel (n=547) in the pivotal studies and received open-label treatment with dapsone gel in the long-term safety study (n=181). In the pivotal studies, success based on achieving a Global Acne Assessment Score (GAAS) of 0 (none) or 1 (minimal) at week 12 was significantly greater for the dapsone gel-treated adolescent participants (40.1%; 232/578) compared with the vehicle gel-treated adolescent participants (28.2%; 154/547) (P<.001). Treatment with dapsone gel in adolescents also resulted in clinically meaningful improvements in acne lesion counts by week 12 in the pivotal studies and for up to 12 months in the long-term safety study. The incidence of adverse events, including application-site events, was low and similar between treatment groups in the pivotal studies and was similarly low in the long-term safety study. Results from the large number of adolescent participants in these 3 studies show that dapsone gel is an effective and safe topical therapy for the treatment of acne vulgaris in adolescents aged 12 to 15 years for up to 12 months.