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.     

Comparing 2.5%, 5%, and 10% Benzoyl Peroxide on Inflammatory Acne Vulgaris

A 2.5% formulation of benzoyl peroxide was compared with its vehicle, and with a 5% and a 10% proprietary benzoyl peroxide gel preparation in three double-blind studies involving 153 patients with mild to moderately severe acne vulgaris. The 2.5% benzoyl peroxide formulation was more effective than its vehicle and equivalent to the 5% and 10% concentrations in reducing the number of inflammatory lesions (papules and pustules). Desquamation, erythema, and symptoms of burning with the 2.5% gel were less frequent than with the 10% preparation but equivalent to the 5% gel. The 2.5% formulation also significantly reduced Propionibacterium acnes and the percentage of free fatty acids in the surface lipids after 2 weeks of topical application.     

A novel gel formulation of clindamycin phosphate-tretinoin is not associated with acne flaring

Concern exists about using topical retinoids on patients with inflammatory acne lesions, fearing that a flare in inflammation will occur. In 3 multicenter, double-blind, randomized, phase 3 trials of a clindamycin phosphate 1.2%-tretinoin 0.025% gel (CLIN/RA), clinical evaluations after 2 weeks of treatment determined if flaring occurred in participants treated with tretinoin gel 0.025% (RA) monotherapy, and the difference in inflammation when treated with the combination formulation. Flaring was assessed as an increase in inflammatory lesions of 10% or greater or 20% or greater versus baseline. Most participants experienced improvement in lesions across treatment groups. Participants with mild acne at baseline treated with RA monotherapy had significantly higher rates of flaring compared with participants treated with vehicle gel (VEH) (P < .001). Treatment with CLIN/RA or clindamycin phosphate gel 1.2% (CLIN) monotherapy resulted in significantly lower rates of flaring than RA or VEH (P < .001 for all). Participants with moderate to severe acne showed no signs of RA-induced flaring. In each comparison, the CLIN/RA combination showed the lowest percentage of increased inflammatory lesions. These results indicate that RA-induced flaring may occur with mild inflammation; combining RA with CLIN prevents this flaring. Participants with moderate to severe inflammatory acne did not show an increase in inflammatory lesions compared with participants treated with VEH. Lack of flaring may result from either the novel vehicle formulation or the antiinflammatory effects of CLIN.     

Erythromycin 2% gel in comparison with clindamycin phosphate 1% solution in acne vulgaris

One hundred two patients with mild to moderate facial acne vulgaris completed a 12-week, investigator-masked, randomized, parallel-group comparison of a gel formation of erythromycin (2%) with clindamycin phosphate 1% solution. Patients were evaluated at a baseline visit and after 4, 8, and 12 weeks of twice-daily treatment. Both medications significantly reduced the numbers of papules and open and closed comedones. No significant differences in lesion count reductions were detected between the treatment groups after 8 and 12 weeks of treatment. By the end of 12 weeks, 48% of the patients in the erythromycin group and 47% in the clindamycin group had good or excellent responses to treatment. No patient was terminated from the study for side effects. Most patients, 65% in the erythromycin 2% gel group and 67% in the clindamycin phosphate 1% solution group, had a favorable impression of the overall cosmetic characteristics of their study medication.     

异维A酸红霉素凝胶联合415nm蓝光治疗轻中度寻常痤疮疗效观察

[摘要] 目的：观察异维A酸红霉素凝胶联合蓝色LED光源治疗轻中度炎性痤疮的疗效。方法：将入选的120例患者随机分为三组,每组40例：一组用417nm蓝色LED光源治疗;一组用异维A酸红霉素凝胶治疗;一组用异维A酸红霉素凝胶联合蓝色LED光源治疗。使用数码相机分别记录治疗前及治疗后2、4、6周丘疹和脓疱的数目变化、观察治疗起效时间、疗效及不良反应。结果：异维A酸红霉素凝胶联合蓝色LED光源可以明显降低痤疮的炎性损害,起效时间较快,治疗结束后炎性损害仍可继续减少。结论：应用异维A酸红霉素凝胶联合417nm蓝色LED光源是治疗轻中度炎性痤疮的良好方法。     

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]     

A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne

A double-blind, randomized study comparing isotretinoin gel (Isotrex), its vehicle base, and benzoyl peroxide was performed on 77 patients with mild to moderate acne vulgaris. The effect of treatment was assessed by acne grade and lesion count. The vehicle base had no effect, but both active groups produced significant improvements. Benzoyl peroxide and isotretinoin significantly reduced non-inflamed lesions at 4 (P < 0.05), 8 (P < 0.01), 12 (P < 0.01) weeks. Benzoyl peroxide had a more rapid effect on inflamed lesions, their being significant reductions at 4, 8 and 12 weeks (P < 0.01), whereas with isotretinoin there was a significant improvement at 12 weeks (P < 0.01). In addition, compared to placebo, both active treatments significantly reduced inflamed and non-inflamed lesions. Acne grade had improved significantly in the benzoyl peroxide group by 4 weeks (P < 0.01) and in the isotretinoin group by 8 weeks (P < 0.05). No significant change in haematological or biochemical parameters occurred. An irritant dermatitis occurred equally with both treatments but was well tolerated by the patients. This data confirms the clinical benefit of benzoyl peroxide in acne. The initial effect of isotretinoin on non-inflamed lesions in this study suggests that the prime mode of action is on comedone formation or separation whereas benzoyl peroxide has an effect on both comedones and inflammation.     

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.     

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.     

异维A酸红霉素凝胶治疗寻常痤疮的多中心随机对照临床研究

目的 比较异维A酸红霉素凝胶与阿达帕林凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 多中心、开放、随机、平行对照研究。按照中国痤疮治疗指南痤疮严重程度标准入选轻、中度（Ⅰ ~ Ⅲ级）寻常痤疮患者192例,纳入疗效分析169例,安全性分析190例。试验组86例,外用异维A酸红霉素凝胶;对照组83例,外用阿达帕林凝胶,均为每晚1次,共用药6周。在基线、治疗2、4和6周时分别记录患者白头粉刺、黑头粉刺、炎性丘疹、脓疱数,评价各时间点患者痤疮严重程度,同时记录皮肤局部耐受性以及其他不良反应。结果 随着治疗时间延长,两组的有效率逐渐提高,总体病情严重程度改善。在治疗6周时,试验组总有效率为51.16%,对照组为40.96%,两组差异无统计学意义（P > 0.05）;但在治疗4周及6周时,试验组患者脓疱及炎性皮损的疗效优于对照组（P < 0.05）,同时试验组痤疮分级较对照组低（P < 0.01）。两组不良反应类似,均表现为局部刺激,可耐受。结论 异维A酸红霉素凝胶治疗轻、中度寻常痤疮总有效率与阿达帕林凝胶类似,对于炎性损害疗效优于阿达帕林凝胶,并且对患者总体严重程度降低更快。     

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 clinical study to determine the efficacy and safety of 1% methotrexate/Azone® (MAZ) gel applied topically once daily in patients with psoriasis vulgaris

The efficacy and safety of an Azone-enhanced topical gel formulation of 1% methotrexate (MAZ), administered once daily for 8 weeks, was compared with that of placebo vehicle for the treatment of severe plaque psoriasis. Fifty-three patients were involved in this double-blind, paired-comparison study. Changes in disease signs and symptoms indicated that both agents have antipsoriatic activity; however, lesions treated with MAZ exhibited significantly greater improvement. At the end of treatment, 27% of MAZ-treated lesions demonstrated marked improvement, whereas none of the placebo-treated lesions exhibited this degree of change. MAZ was most effective in reducing lesional scaling and thickness ( P  < 0.05 vs. placebo). Thirty-seven patients experienced adverse events. The majority were local in nature and mild to moderate in degree. No clinically significant changes in hematologic or clinical laboratory parameters were observed, and concentrations of methotrexate were demonstrable in only two of 296 plasma samples. The findings suggest that the MAZ formulation provides percutaneous absorption of methotrexate in amounts sufficient for a beneficial effect in psoriasis, but insufficient to exert systemic toxicities.     

Acne treatment with topical erythromycin and zinc: effect of Propionibacterium acnes and free fatty acid composition

A double-blind investigation has been conducted to examine the effect of topical 4% erythromycin/1.2% zinc acetate solution and its vehicle on quantitative bacterial counts (skin surface washings) of propionibacterium acnes and the free fatty acids of the skin surface. The logarithmic counts for P. acnes in the erythromycin/zinc group showed a significant reduction (98%) following 10 weeks of therapy. This compared with a 43% change shown for the vehicle-control group. A significant reduction (69%) in the percentage of free fatty acids in the surface lipids was seen at week 4 in the erythromycin/zinc group as compared to the control group. Triglyceride levels were significantly increased at all time points for the erythromycin/zinc group as compared to the control group. There was also a significant decrease (69%) in inflammatory lesions shown for the erythromycin/zinc treatment group at week 8 as compared to a 9% reduction in the control group.     

A calcipotriene/betamethasone dipropionate two-compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients: results of the randomized, 8-week, double-blind phase of a clinical trial

The calcipotriene/betamethasone dipropionate two-compound scalp formulation has been shown to be safe and effective in the treatment of scalp psoriasis over 8 weeks, but the patients studied were mainly White and non-Hispanic. The aim of this study was to evaluate the efficacy and safety of the two-compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients. A total of 99 Hispanic/Latino and 78 Black/African American patients were randomized double-blind in a 3:1 ratio to 8 weeks of once daily treatment of scalp psoriasis with either the two-compound scalp formulation (n=135) or its vehicle (n=42). In the two-compound group, 71.9% of patients had cleared or minimal disease at week 8 by the investigator's global assessment compared to 40.5% in the vehicle group (odds ratio 3.30; 95% CI 1.62-6.72; P<0.001). For the five secondary efficacy response criteria, three (total sign score, thickness of scalp psoriasis, patient's global assessment) showed that two-compound scalp formulation was statistically significantly more effective than its vehicle, and the other two (redness and scaliness of scalp psoriasis) approached statistical significance in favor of the two-compound scalp formulation. There was no statistically significant difference (P=1.00) between the percentage of patients with adverse reactions in the two-compound group (7.0%) and the vehicle group (7.9%). The two-compound scalp formulation is safe and effective in the treatment of scalp psoriasis over 8 weeks in Hispanic/Latino and Black/African American patients.     

A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial

OBJECTIVE: To compare the efficacy and safety of a novel formulation of 15% azelaic acid gel (Finacea; Berlex Laboratories, Inc, Montville, NJ) with 0.75% metronidazole gel (MetroGel; Galderma Laboratories LP, Fort Worth, Tex) as topical therapy for moderate, papulopustular facial rosacea. DESIGN: Multicenter, double-blind, randomized, parallel-group study. SETTING: Thirteen US centers. PATIENTS: A total of 251 patients with papulopustular rosacea with persistent erythema and telangiectasia. INTERVENTIONS: Patients were randomized to receive azelaic acid gel or metronidazole gel twice daily for 15 weeks. MAIN OUTCOME MEASURES: Nominal and percent change in inflammatory lesion count, change in erythema and telangiectasia severity ratings, investigator's global assessment of rosacea, and investigator's and patient's overall improvement ratings. RESULTS: Azelaic acid gel was superior to metronidazole gel in reduction of mean nominal lesion count (-12.9 vs -10.7, respectively) (P =.003) and mean percent decrease in inflammatory lesions (-72.7% vs -55.8%, respectively) (P<.001). With respect to erythema severity, 56% of azelaic acid gel-treated patients were rated improved vs 42% of metronidazole gel-treated patients (P =.02). The effectiveness of metronidazole gel on these variables seemed to plateau after week 8, whereas azelaic acid gel demonstrated progressive improvement through week 15. Neither treatment had a clinically appreciable effect on telangiectasia. Both the investigator's global assessment (P =.02) and overall assessment of improvement (P =.005) showed a significant therapeutic advantage for azelaic acid gel. Azelaic acid gel also scored higher on the patient's overall assessment of efficacy. Both treatments were rated as having high cosmetic acceptability. No serious or systemic treatment-related adverse events were reported in either group. CONCLUSION: Use of 15% azelaic acid gel twice daily for 15 weeks demonstrated significant superiority over using 0.75% metronidazole gel in improving principal signs of rosacea (inflammatory lesions and erythema).     

Topical erythromycin vs blank vehicle in a multiclinic acne study

A stable solution of erythromycin was developed using a vehicle of ethanol, propylene glycol, and citric acid buffer. In a controlled, randomized, double-blind comparison, a 2% solution of erythromycin applied to moderately severe facial acne was found to be superior to the blank vehicle in reducing the number of inflamed papules. During a period of 12 weeks, such papules were reduced by 56% in the erythromycin group, compared with 33% in the blank vehicle group. In the erythromycin group, 62% of the subjects had a good or excellent response, compared with 27% of those in the blank vehicle group. Adverse effects were similar in type in both groups and included redness, scaling, dryness, oiliness, burning, itching, and irritation of the eyes. No allergic reactions or skin infections were encountered.     

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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.     

Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: a randomized, multicenter, investigator-blinded, controlled study

BACKGROUND: Topical retinoids, such as adapalene, are an integral part of acne therapy in most regions and are considered appropriate first-line therapy by international guidelines for all cases of acne with the exception of the most severe. However, there are currently no topical retinoids available for the treatment of acne vulgaris in Japan. OBJECTIVE: To confirm efficacy and safety of adapalene gel 0.1% versus the corresponding gel vehicle in the treatment of Japanese patients with acne vulgaris for up to 12 weeks. METHODS: A total of 200 patients were randomized to receive adapalene gel 0.1%, or vehicle once-daily for 12 weeks. Percent reduction in lesion counts (total, inflammatory, and non-inflammatory) and subject satisfaction were evaluated. Safety was monitored through adverse events and laboratory tests. RESULTS: Adapalene gel 0.1% produced significantly better reductions in total (P<0.0001), inflammatory (P=0.0010), and non-inflammatory lesions (P<0.0001) at endpoint (week 12, last observation carried forward) than gel vehicle, with a higher overall subject satisfaction. The primary efficacy variable, the median percent reduction of total lesion counts at endpoint, was significantly greater with adapalene gel 0.1% (63.2%) compared to that with the vehicle (36.9%) in the ITT population (P<0.0001). Significantly greater results were observed as early as week 1. Adapalene was well tolerated, with adverse events that were mostly mild-to-moderate and transient in nature. CONCLUSIONS: Adapalene gel 0.1% was effective in the treatment of acne vulgaris in Japanese patients. Adapalene was safe and well tolerated, consistent with the good tolerability profile demonstrated in other patient populations.     

Double-blind group comparison of topical meclocycline, erythromycin and placebo in the treatment of papulo-pustulosa acne

Ten institutions participated in a controlled clinical trial in order to evaluate the efficacy of topical meclocycline and erythromycin in comparison to placebo with regard to papulopustular acne. Both drugs had been incorporated in the same galenic formulation that served as placebo. The vehicle employed in this study guaranteed equally favorable drug relies for both preparations. At the end of the trial, 419 patients could be evaluated for efficacy. As impartial criterion for evaluation, the number of inflammatory lesions on the right side of the face was counted before and after three months of treatment. In addition, we recorded the patients' and physicians' overall judgment at the end of the study. As compared with placebo, meclocycline as well as erythromycin brought about statistically significant improvement already after two months of treatment. After three months, the results were statistically very highly significant (p less than 0.001). At any time of the study, there could not be demonstrated any difference between the two groups treated with meclocycline and erythromycin.     

Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter,randomized, double‐blind,vehicle‐controlled,parallel‐group study

Benzoyl peroxide (BPO) as an anti‐acne medication is not yet approved in Japan. This study evaluated the efficacy and safety of a once‐daily topical application of BPO 3% gel versus an inert vehicle gel in Japanese acne patients. Three hundred and sixty patients were randomized to receive BPO 3% or vehicle for 12 weeks. The primary efficacy end‐point was absolute change in number of total lesions (TL) from baseline to week 12 to demonstrate the superiority of BPO 3% versus vehicle. Secondary efficacy end‐points were absolute and percent change in TL, inflammatory lesions (IL), non‐inflammatory lesions (non‐IL) and Investigator's Static Global Assessment (ISGA). Change in TL counts from baseline to week 12 for BPO 3% was superior to vehicle (difference, ?21.0; P < 0.001). Absolute and percent reductions in TL, IL and non‐IL counts were greater for BPO 3% at all study visits. The proportion of patients with improvement in ISGA scores was significantly higher with BPO 3% than with vehicle from week 2. All adverse events were mild or moderate. Adverse drug‐related reactions were higher for BPO 3% (30%) than with vehicle (5%). Local tolerability scores of grade 1 or more (slight to moderate) were more frequent with BPO 3% than vehicle with the most significant differences observed in dryness (56% vs 27% at week 1–4), peeling (19% vs 9% at week 1–2) and burning/stinging (58% vs 15% at week 1–12). These results indicate that BPO 3% is effective while maintaining a favorable safety and tolerability profile in Japanese acne patients.