A Novel Gel Formulation of 0.25% Tretinoin and 1.2% Clindamycin Phosphate: Efficacy in Acne Vulgaris Patients Aged 12 to 18 Years

Abstract:  Treatments for mild to moderately severe acne usually combine retinoid and antimicrobial therapy. Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12-week, multicenter, double-blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52-week safety follow-up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA's effects on acne lesion prevalence in 12- to 18-year-old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p ≤ 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris.
[Abstract amended after online publication date June 8, 2009]     

5%过氧苯甲酰凝胶联合0.025%维A酸乳膏治疗寻常痤疮疗效观察

目的观察5%过氧苯甲酰凝胶和0.025%维A酸乳膏联合治疗寻常痤疮的疗效。方法治疗组34例,5%过氧苯甲酰凝胶和0.025%维A酸乳膏联合治疗,对照组33例,0.025%维A酸乳膏治疗,共8周。疗程结束观察疗效。结果治疗组有效率91.18%,对照组为66.67%,两组差异有显著性(P<0.05)。结论5%过氧苯甲酰凝胶和0.025%维A酸乳膏联合治疗痤疮的疗效满意。     

阿达帕林凝胶联合过氧苯甲酰凝胶治疗寻常痤疮的多中心随机对照研究

目的评价阿达帕林凝胶联合过氧苯甲酰凝胶治疗轻中度寻常痤疮的疗效和安全性。方法随机、多中心、开放、平行对照研究。按照痤疮严重程度国际改良标准入选轻、中度寻常痤疮患者。试验组早晨外用5%过氧苯甲酰凝胶1次,晚睡前外用0.1%阿达帕林凝胶1次;对照组仅晚睡前外用0.1%阿达帕林凝胶1次。共用药12周,在基线、2、4、8和12周时记录炎性皮损、非炎性皮损和总皮损数,皮肤局部刺激反应如红斑、脱屑、干燥、烧灼/刺痛的评分,以及其他不良反应。结果3个中心共入选150例患者。试验组、对照组的总有效率在第8周分别为74.6%和56.7%(P<0.05);在第12周时分别为81.3%和68.9%(P>0.05)。局部刺激反应评分除烧灼/刺痛在第4、8周时两组间的差异有显著性外,其余差异均无显著性。另外,两组各有2例发生接触性皮炎。结论0.1%阿达帕林凝胶合用5%过氧苯甲酰治疗轻中度寻常痤疮较0.1%阿达帕林凝胶单用疗效显著,见效快,病程短,未增加不良反应。     

0.1%阿达帕林凝胶和2%夫西地酸乳膏联合外用治疗寻常痤疮疗效观察

目的探讨痤疮的有效治疗方法。方法治疗组30例采用阿达帕林凝胶和夫西地酸乳膏联合治疗,对照组28例采用夫西地酸乳膏治疗,8周后结束观察并总结。结果治疗组有效率86.7%,对照组有效率64.3%,两组比较差异有显著性(P<0.05)。结论阿达帕林凝胶和夫西地酸乳膏联合治疗痤疮疗效满意。     

过氧化苯甲酰凝胶和维胺酯乳膏治疗寻常痤疮

目的　观察 5%过氧化苯甲酰凝胶联合 0 .3 %维胺酯乳膏治疗寻常痤疮的有效性与安全性。方法　两药联用与单用 5%过氧化苯甲酰凝胶进行比较。结果　联用组有效率为 83 .6% ,显著优于单用组 ;两组不良反应差异无显著性。结论　联用疗法安全方便 ,疗效确实     

阿达帕林凝胶个体化治疗寻常痤疮的临床研究

目的 评价0．1％阿达帕林凝胶个体化治疗寻常痤疮的疗效和安全性。方法 81例轻、中度寻常痤疮患者，根据个体情况每日外用0．1％阿达帕林凝胶1．3次，总疗程6～8周。随机选择其中30例每周复诊，拍摄照片观察比较，指导调整治疗剂量。结果 81例和其中30例痤疮患者痊愈率(总皮损数减少≥90％)分别为44．4％和73．4％；治疗中，皮脂溢出减少发生率83．3％；不良反应发生率39．5％，未影响治疗。结论 本药个体化治疗寻常痤疮疗效良好，合理地增加日用药剂量可提高痊愈率；本药刺激性较低，患者皮肤对此药耐受性较好：疗程中阿达帕林凝胶可明显减少皮脂溢出。     

0.1%他扎罗汀凝胶接触治疗寻常痤疮疗效观察

目的：观察0．1％他扎罗汀凝胶短期接触治疗轻、中度面部寻常痤疮的临床疗效和安全性。方法：采用随机、平行对照的临床研究方法，入选病例外涂试验药物，每天2次，疗程12周。结果：治疗组疗后2、4、8、12周的有效率分别为24％、40％、60％、68％；对照组分别为19．2％(P=0．631)、23．1％(P=0．175)、30．8％(P=0．034)、30．8％(P=0．008)。结论：0．1％他扎罗汀凝胶短期接触治疗轻中度面部寻常痤疮疗效好，不良反应轻，有较好的耐受性。     

Management of Psoriasis Vulgaris with Methotrexate 0.25% In a Hydrophilic Gel: A Placebo-Controlled, Double-Blind Study

Background: Methotrexate has been used as one of the first and systemic therapies for psoriasis. In general, 70% of patients with psoriasis prefer topical therapy as the treatment of choice. Objective: The purpose of this placebo-controlled double-blind study was to evaluate the clinical efficacy and tolerability of methotrexate 0.25% incorporated in a hydrophilic gel (hydroxyethylcellulose 1%) to treat patients afflicted with psoriasis vulgaris. Methods: Sixty patients (37M/23F) ranging between 18 and 70 years of age, with slight to moderate chronic plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores between 5.3 and 17.5 joined the study. The mean duration of the disease at entry was 9.6 years (range 1-24 years). The diagnosis of psoriasis was established by clinical and histopathologic methods. Patients were sequentially randomized into two parallel groups. Each patient was allocated a precoded 100-g tube (active or placebo) with instructions on how to self-administer the trial medication topically (without occlusion) to their lesions two times daily for 5 consecutive days per week. The study lasted for 12 weeks with 4 weeks of active treatment. Patients were examined on a weekly basis and those showing total clearing or remission of lesions were considered effectively treated. Results: By the end of the treatment, breaking the code disclosed that methotrexate 0.25% gel had significantly treated more patients than placebo (83.3% vs. 6.7%; p < 0.0001), reduced the PASI score to a mean of 2.2, and cleared more plaques (82.2% vs. 4.3%; p < 0.0001). Laboratory evaluations, including CBC with differential and platelet count, renal function, liver chemistry [SGOT (aspartate transaminase) and SGPT (alanine transaminase)], and serum creatinine, were within the normal limits. The treatment was well-tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. The study was followed up for 12 months from the first day of the treatment; two cured patients had relapsed after 8 months. Conclusion: The findings of this study demonstrate that methotrexate 0.25% in a hydrophilic gel is well tolerated and significantly more effective than placebo as a patient-applied topical medication to treat psoriasis vulgaris.     

中药治疗寻常型银屑病的Meta分析

目的利用Meta分析探讨中药治疗银屑病的临床疗效。方法计算机检索Cochrane图书馆临床对照试验库、MEDLINE、ELSEIVER数据库、Pubmed数据库、中国学术期刊全文数据库(CNKI)、万方数据库、维普期刊数据库、中国生物医学文献数据库(CBM),检索相关会议论文及所获文献的参考文献,收集中药治疗银屑病的临床RCT文献。由2名独立的研究者分别检索文献、提取资料,并按照Cochrane系统评价的方法严格评价纳入研究的质量并提取有效数据,然后应用Cochrane协作网提供的Rev Man5.3软件进行Meta分析。结果共纳入16个临床RCT。Meta分析结果显示:中药组总有效率、银屑病面积和严重程度指数(PASI)评分优于西药组,进一步分析,中药组优于阿维A胶囊组、迪银片组。结论中药治疗银屑病疗效优于阿维A胶囊、迪银片,但由于纳入文献的方法学质量较低,仍需要进行严格的多中心、大样本的随机双盲对照试验,提供高质量的临床证据。     

Topical Retinoids in Acne Vulgaris: A Systematic Review

Background

Topical retinoids are a first-line treatment for acne vulgaris.

Objective

This systematic review aims to evaluate the efficacy, safety, and tolerability of topical retinoids approved in the United States for the treatment of acne vulgaris.

Methods

A PubMed and Embase search was conducted using the search terms ‘adapalene,’ ‘tretinoin,’ ‘tazarotene,’ and ‘acne vulgaris.’ Selection of articles fit the following inclusion criteria: clinical trials evaluating both efficacy and safety/tolerability of topical retinoids approved in the United States for the treatment of acne vulgaris and published between January 1, 2008 and September 1, 2018. Exclusion criteria included clinical trials involving 20 subjects or fewer, subjects under 12 years of age, and topical retinoid combination therapies with moisturizers or aloe vera. Of 424 search results found, a total of 54 clinical trials were chosen based on selection criteria.

Results

Topical retinoids are superior to vehicle in improving Investigator Global Assessment and Investigator’s Static Global Assessment (24.1–28.8% and 13.3–17.3%, respectively; p < 0.001). A topical retinoid combined with benzoyl peroxide led to IGA improvement compared with vehicle (26.1–34.9% vs 7–11.8%; p < 0.001) at Week 12. Topical retinoid plus an oral antibiotic was superior to vehicle in reducing lesion counts (64–78.9% vs 41–56.8%, p < 0.001). There was no significant difference in efficacy between tretinoin and tazarotene. Tretinoin 0.05% resulted in 62% of patients experiencing AEs compared with adapalene 0.1% (19%) and adapalene 0.3% (40%). More patients receiving adapalene were tolerant of the AEs compared with tazarotene (55.4% vs 24.4%; p < 0.0012).

Conclusions

Topical retinoids are safe and efficacious for the treatment of acne vulgaris. They should be used in combination with benzoyl peroxide to optimize results in patients. The differences in efficacy of topical retinoids appears minor; therefore, the type of topical retinoid is not as important as choosing a particular strength of topical retinoid and combining it with an antimicrobial agent. Adapalene has a superior tolerability profile amongst topical retinoids.

     

润燥止痒胶囊联合盐酸美他环素治疗寻常性痤疮疗效观察

目的观察润燥止痒胶囊联合盐酸美他环素治疗寻常性痤疮的临床疗效和安全性。方法106例寻常性痤疮患者,随机分为治疗组56例,口服润燥止痒胶囊4粒,3次/d,盐酸美他环素片200mg,2次/d;对照组50例,口服盐酸美他环素片200mg,2次/d,两组均予复方氯霉素酊早1次外用、姜黄消痤搽剂晚1次外用,疗程均为6周。结果治疗组治愈率和有效率分别为53.57%和83.93%,均明显优于对照组(治愈率34.00%;有效率66.00%),且无明显不良反应。治疗组复发率明显低于对照组(10.71%vs.26.00%)。结论润燥止痒胶囊联合盐酸美他环素治疗寻常性痤疮疗效好、安全性高、复发率低。     

Treatment of Acne Vulgaris with Topical Clindamycin Phosphate: A Double-Blind Study

In a double-blind study, 1% clindamycin phosphate in aqueous-alcohol vehicle was compared with the vehicle alone on the opposite side. Of 29 patients evaluated, the clindamycin-treated side was found to be better in 11, the placebo side was better in four, and both sides were improved in five. No benefit was found in the remaining nine patients. These results were not considered statistically significant. Following discontinuance of treatment a prominent flare was noted in 14 of 19 patients who had previously improved on one side or the other, and this was considered significant (p less than .05). One percent clindamycin phosphate in equal parts of alcohol and water is apparently beneficial for some, but not for all patients with inflammatory acne.     

Acne Vulgaris in Preadolescent Children: Recommendations for Evaluation

Acne vulgaris in infants and children often triggers extensive laboratory evaluation out of concern about associated endocrinopathy. Clinical parameters to help guide evaluation of these children have not been defined. This was a retrospective chart review of 24 preadolescent patients with acne and a review of related medical literature. Two age‐related subsets were identified: 12 patients who developed acne before the age of 15 months, 75% male, with comedonal and inflammatory lesions; and 12 patients who developed acne between the ages of 2 and 7 years, 75% female, with primarily comedonal lesions. Laboratory evaluation in 13 of the patients was unremarkable. Bone age was advanced in 1 of the 11 children imaged. Premature adrenarche was diagnosed in four patients; all four had additional clinical signs of puberty and growth parameters >90th percentile. None required additional treatment. Our cohort of preadolescent children presenting with acne included an equal number of patients in two distinct subsets: infantile and childhood‐onset acne. Literature review identified a rare third subset presenting with acne, signs of advanced puberty, and associated endocrinopathy. There was no evidence of endocrinopathy in our patients with infantile acne. Two‐thirds of our patients with childhood‐onset acne had no additional clinical signs of puberty and no evidence of endocrinopathy. A focused history and physical examination is sufficient to evaluate the majority of infants and children with acne. Hand X‐ray for bone age is a useful screening test. Further evaluation and endocrinology referral are warranted in preadolescents with acne and advanced bone age or additional clinical evidence of early puberty.     

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review

American Journal of Clinical Dermatology - The management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen...     

Effects of Adapalene-Benzoyl Peroxide Combination Gel in Treatment or Maintenance Therapy of Moderate or Severe Acne Vulgaris: A Meta-Analysis

Background

An antibiotic-free, fixed-dose combination gel with adapalene (A) 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for treatment of acne vulgaris.

Objective

To compare the clinical outcomes of A-BPO combination gel with vehicle gel for treatment or maintenance therapy of patients with acne vulgaris.

Methods

An electronic search of the database PubMed (1966 to September 2012), Embase (1984 to September 2012), and Cochrane Controlled Trials Register (CENTRAL; 3rd Quarter, 2012) was undertaken to identify relevant studies. Main clinical outcomes were success rate, treatment-related adverse events (AEs), AEs leading to discontinuation, satisfaction with the effectiveness, and overall satisfaction.

Results

Six studies were finally included in this meta-analysis. The A-BPO group yielded better clinical outcomes regarding the success rate (p<0.00001), satisfaction with the effectiveness of treatment (p=0.005), and overall satisfaction (p=0.005) compared to the vehicle group. The incidence of treatment-related AEs in the A-BPO group was comparable with that of vehicle group (p=0.09), while the A-BPO group was associated with a slightly increase in the incidence of AEs leading to discontinuation when compared with the vehicle group (p=0.02).

Conclusion

A-BPO combination gel yields better clinical outcomes including success rate, satisfaction with the effectiveness, and overall satisfaction compared to vehicle gel, despite an increased incidence of AEs leading to discontinuation. The A-BPO combination agent most likely contributes to the treatment of moderate acne vulgaris rather than severe acne vulgaris, but it may be useful in maintenance therapy of patients with severe acne vulgaris.