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.     

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。     

An evaluation of a 2% erythromycin ointment in the topical therapy of acne vulgaris

Two hundred eight patients completed a 12-week, multicenter, double-blind, controlled study comparing a 2% erythromycin ointment to its vehicle. Patients were evaluated by inflammatory lesion counts and Cook acne severity grade at the initial visit and at weeks 2, 4, 8, 10, and 12. The 2% erythromycin ointment proved to be statistically more effective than the vehicle in reducing lesion counts and acne severity grade at weeks 4, 8, 10, and 12. The ointment caused few side effects and was well tolerated by most patients.     

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 comparative efficacy of benzoyl peroxide 5%/erythromycin 3% gel and erythromycin 4%/zinc 1.2% solution in the treatment of acne vulgaris

This randomized 10–week study compared the efficacy of benzoyl peroxide 5%/erythromycin 3% gel with erythromycin 4%/zinc 1.2% solution in 72 acne vulgaris patients. Physician global evaluations were significantly more improved (P 0.05) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group compared to erythromycin 4%/zinc 1.2% solution at week 2 and at each subsequent biweekly clinical visit. Inflammatory lesions (papules/pustules) were significantly more reduced (P 0.005) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group than the erythromycin 4%/zinc 1.2% solution at weeks 4 and 10. Comedones were significantly more reduced (P 0.001) in the benzoyl peroxide 5%/erythromycin 3% gel treatment group than in the erythromycin 4%/zinc 1.2% solution group at weeks 8 and 10. Patient efficacy evaluations significantly (P 0.001) favoured benzoyl peroxide 5%/erythromycin 3% gel to erythromycin 4%/zinc 1.2% solution.     

Benzoylperoxide versus topical erythromycin in the treatment of acne vulgaris

In a double-blind clinical study in ninety-four subjects a 1.5% (w/v) erythromycin lotion was as effective as 5% (w/v) benzoyl peroxide gel in significantly reducing the number of small inflamed lesions and the overall acne severity. However, benzoyl peroxide also significantly reduced the number of non-inflamed lesions whereas erythromycin had no effect on these lesions. This study supports the view that, although topical erythromycin is of value in the treatment of mild or moderate acne vulgaris, long established, safe and effective remedies should not be replaced by topical antibiotics until more comparative studies and investigations on bacterial resistance have been completed.     

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.     

A 4% erythromycin and zinc combination (Zineryt®) versus 2% erythromycin (Eryderm®) in acne vulgaris: a randomized, double-blind comparative study

A double-blind, randomized multi-centre study was performed to evaluate the efficacy of a 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm). One-hundred and twenty-two patients suffering from acne vulgaris were treated with either Zineryt lotion or 2% erythromycin lotion. Acne grading and lesion counts for comedones, papules, pustules, nodules and macules were performed at each visit at 0, 1, 2, 4, 8 and 12 weeks. Treatment with Zineryt lotion was found to be more effective than with 2% erythromycin as regards the reduction in number of the acne lesions and the severity grade of the acne.     

Combined 0.1% retinaldehyde/ 6% glycolic acid cream in prophylaxis and treatment of acne scarring

BACKGROUND: Acne often results in permanent, badly tolerated, difficult to treat scars. OBJECTIVE: To evaluate the efficacy and safety of a 0.1% retinaldehyde/6% glycolic acid (RALGA) cream at preventing and treating acne scarring in patients previously treated for moderate acne. METHODS: A double-blind vehicle-controlled study was conducted in 145 patients randomized to apply RALGAor vehicle cream every evening for 3 months. Global scarring score and patient's assessment of global efficacy, then residual acne lesions, quality of life and tolerance were evaluated at inclusion and each month until study completion. RESULTS: Global scarring score, number of inflammatory lesions and comedones significantly improved in each group from day 28 (p<0.0001). Number of inflammatory lesions were significantly decreased only in the RALGA group. RALGA cream was more efficient than vehicle on scarring after 3 months in compliant patients (p=0.007) due to erythema and hyperpigmentation improvement. CONCLUSION: RALGA cream is efficient at preventing and treating acne scarring in patients with moderate acne.     

0.1%他扎罗汀乳膏短时接触治疗寻常痤疮的疗效观察

［目的］对比观察及评价0.1%他扎罗汀乳膏短时接触治疗与常规每日一次治疗轻中度寻常型痤疮的疗效和安全性。［方法］采用前瞻性开放性对照观察,选用重庆华邦公司0.1%他扎罗汀乳膏局部外用面部轻中度痤疮,短时接触疗法为每晚1次,5分钟后洗去,常规疗法为每晚1次过夜,疗程均为8周,于第1、2、4、8周进行复诊随访。短时接触治疗组为52例,常规治疗组为49例。［结果］第8周时0.1%他扎罗汀短时接触治疗组有效率为69.1%,常规治疗组有效率为75.1%,X2=6.501,P=0.09＞0.05,两组疗效之间无显著统计学差异。不良反应发生率短时接触治疗组为21.2%,常规治疗组为44.9%,X2=8.538,P=0.036＜0.05,两组不良反应发生率有显著统计学差异,短时接触治疗组明显低于常规治疗组。［结论］他扎罗汀短时接触治疗寻常型痤疮安全、有效,值得临床推广应用。     

Comparison of efficacy of topical clindamycin and nicotinamide combination with plain clindamycin for the treatment of acne vulgaris and acne resistant to topical antibiotics

A total of 75 patients with inflammatory acne vulgaris were divided into three groups. Group A was treated with combination of 4% nicotinamide and 1% clindamycin combination, Group B was treated with plain 1% clindamycin and Group C which was considered to have resistance to local antibiotics due to no response to treatment was treated with the combination. At the end of 8 weeks the results were compared. It was concluded that addition of nicotinamide was of not much value in treating inflammatory acne and results were some as for plain clindamycin and also the combination did not offer much relief in treatment of resistant acne.     

Clinical evaluation of a new erythromycin solution for acne vulgaris

The effects of a 1.5 percent solution of erythromycin, especially formulated for the topical treatment of acne vulgaris, were compared with those of its vehicle in a twelve week, double-blind study involving twenty-six patients. A statistically significant difference between the responses to the two treatments was seen in both lesion counts and overall evaluations. The final reductions in the mean number of papules and pustules in the erythromycin group were 70.8 and 77.6 percent of the initial values, respectively, and the overall evaluations of this group showed that 91.7 percent of the patients had achieved good or excellent results. A group of fourteen patients continued therapy with the erythromycin solution for an additional nine months. Effective control of their acne was maintained, and no serious side effects were observed.     

A double-blind study of the effectiveness of a 3% erythromycin and 5% benzoyl peroxide combination in the treatment of acne vulgaris

One hundred sixty-five subjects completed a 10-week, double-blind controlled study comparing the following: (1) a combination of 3% erythromycin and 5% benzoyl peroxide in a gel, (2) 5% benzoyl peroxide gel, (3) 3% erythromycin gel, and (4) the gel vehicle. The benzoyl peroxide gel and the erythromycin gel were superior to the control gel; however, the combination product was more effective than any of the others. This was true for both pustular and papular lesions, but the most dramatic effect was on combined inflammatory lesions, i.e., papules and pustules.     

A placebo-controlled clinical trial to compare a gel containing a combination of isotretinoin (0.05%) and erythromycin (2%) with gels containing isotretinoin (0.05%) or erythromycin (2%) alone in the topical treatment of acne vulgaris

PURPOSE: To compare the clinical benefit of isotretinoin (0.05%) and erythromycin (2%) gels alone and in combination (Isotrexintrade mark) in acne patients. PROCEDURE: The study was a randomised placebo-controlled trial in acne patients who should benefit from topical therapy. RESULTS: All treatment groups except placebo produced a time-related reduction in lesion counts, with the combined therapy producing the largest mean decrease. Between-group comparisons showed several significant differences. CONCLUSION: Isotrexin was significantly better than placebo at all time points for inflamed and total lesions, and was better than isotretinoin at week 4. Side-effects were minimal.