A combination benzoyl peroxide and clindamycin topical gel compared with benzoyl peroxide, clindamycin phosphate, and vehicle in the treatment of acne vulgaris

A topical gel combining 5% benzoyl peroxide and 1% clindamycin as phosphate was evaluated in a 10-week randomized double-blind trial involving 287 patients with moderate to moderately severe acne. The combination agent demonstrated significantly greater reductions in inflammatory lesions than either of its active constituents (5% benzoyl peroxide and 1% clindamycin) or vehicle when used alone. Significantly greater reductions in comedos and improvements, as measured by both physicians' and patients' global evaluations, were obtained with the combination agent than with clindamycin or vehicle. The reduction in comedos and the global improvements were similar between the combination agent and benzoyl peroxide. The combination agent was well tolerated; the incidence of dry skin was similar to that found with benzoyl peroxide, and other adverse events were similar to that with vehicle. The improved efficacy obtained with combination therapy was accompanied by a safety profile similar to that of either constituent used alone.     

A comparative study of benzoyl peroxide and clindamycin phosphate for treating acne vulgaris

A water based 5% benzoyl peroxide gel (Benzac W5) was compared with topical 1% clindamycin phosphate solution (Cleocin T) in the treatment of acne vulgaris using a randomized, investigator blind study design. Lesion counts were significantly reduced in both treatment groups over the 12-week study period; however, the reduction of total lesions produced by benzoyl peroxide gel was significantly greater than that produced by clindamycin phosphate (P less than 0.05). Clindamycin phosphate had a milder effect on the skin surface in terms of peeling and drying than the benzoyl peroxide gel.     

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.     

Efficacy of the addition of salicylic acid to clindamycin and benzoyl peroxide combination for acne vulgaris

Clindamycin phosphate (CDP), benzoyl peroxide (BPO) and salicylic acid (SA) are known to be effective acne therapy agents depending on their anti-inflammatory and comedolytic properties. The purpose of this study was to investigate the efficacy and tolerability of the addition of SA treatment to CDP and BPO (SA and CDP + BPO) and compare it with CDP + BPO in patients with mild to moderate facial acne vulgaris. Forty-nine patients were enrolled in a 12 week prospective, single-blind, randomized, comparative clinical study. Efficacy was assessed by lesion counts, global improvement, quality of life index and measurements 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. There were statistically significant differences between treatment groups for reductions in NIL counts beyond 2 weeks, IL counts and TL counts throughout the all study weeks, and global improvement scores evaluated by patients and investigator at the end of the study in favor of SA and CDP + BPO treatment when compared to CDP + BPO treatment. Both combinations significantly decreased stratum corneum hydration, although skin sebum values decreased with SA and CDP + BPO treatment. These combinations were also well tolerated except significantly higher frequency of mild to moderate transient dryness in patients applied SA and CDP + BPO. The addition of SA to CDP + BPO treatment demonstrated significantly better and faster results in terms of reductions in acne lesion counts and well tolerated except for higher frequency of mild to moderate transient dryness.     

Topical meclocycline sulfosalicylate, benzoyl peroxide, and a combination of the two in the treatment of acne vulgaris.

One hundred and six patients with acne vulgaris of the face were treated for 10 weeks with either topical meclocycline sulfosalicylate, topical benzoyl peroxide or both preparations. A randomized, double-blind parallel group study was used. Benzoyl peroxide proved more effective than meclocycline in reducing acne lesion counts, while local side effects were more common in the benzoyl peroxide-treated patients. The combined treatment was of intermediate efficacy with fewer local side effects.     

A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide and adapalene in the treatment of mild to moderate facial acne vulgaris

BACKGROUND: Antibiotics are often combined with other agents to provide topical acne treatments that are effective against both inflammatory and noninflammatory lesions and minimize the development of antibiotic resistance. Retinoids and associated treatments also have anti-inflammatory activity and decrease microcomedo formation. To date, few direct comparisons of these different acne treatments have been conducted. OBJECTIVES: To compare the clinical effectiveness of two treatments for facial acne: a ready-mixed once-daily gel containing clindamycin phosphate 10 mg mL(-1) + benzoyl peroxide 50 mg mL(-1) (CDP + BPO; Duac; Stiefel, High Wycombe, U.K.) and a once-daily gel containing adapalene 0.1% (ADA; Differin; Galderma, Watford, U.K.). METHODS: In this assessor-blind, randomized study; 65 patients were treated with CDP + BPO once daily and 65 patients with ADA once daily. The treatment period was 12 weeks and lesion counts, acne grade and global improvement were assessed at weeks 1, 2, 4, 8 and 12. RESULTS: CDP + BPO showed an earlier onset of action with a faster significant reduction in inflammatory and total lesion counts than ADA. A between-group comparison of the percentage change from baseline showed that CDP + BPO was statistically significantly superior to ADA from week 1 onwards both for inflammatory lesions (P < or = 0.001) and for total lesions (P < or = 0.004). While 76% of inflammatory lesions remained at week 2 for patients using ADA, in contrast, only 55% of inflammatory lesions remained at week 2 in the CDP + BPO group, resulting in a treatment effect of 1.38. Thus CDP + BPO removed 38% more inflammatory lesions than ADA at this timepoint. The trend in favour of CDP + BPO, although less marked, continued to the end of the study. CDP + BPO was better tolerated than ADA, with a greater proportion of ADA-treated patients experiencing treatment-related adverse events. Adjunctive topical or oral agents and their impact on acne were not studied in this trial. Due to product differences, this study could not be double blinded but was only single (assessor) blinded. CONCLUSIONS: CDP + BPO and ADA are both effective treatments for acne, but CDP + BPO has a significantly earlier onset of action, is significantly more effective against inflamed and total lesions and is better tolerated, which should improve patient compliance.     

Motretinide versus benzoyl peroxide in the treatment of acne vulgaris

30 patients with acne vulgaris were treated topically with motretinide 0.1% vanishing cream or benzoyl peroxide 5% gel in an open study. Good results were obtained in both groups. Benzoyl peroxide caused local irritation in 73% of the patients, whereas motretinide was well tolerated except in 1 case. Motretinide is considered an alternative in the treatment of papulopustular acne in young adults.     

Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris

The multiple etiologic factors involved in acne vulgaris make the use of several medications necessary to treat the condition. Use of a fixed combination of clindamycin phosphate 1.2% and tretinoin 0.025% in conjunction with a benzoyl peroxide (BPO) wash 4% targets several pathologic factors simultaneously and mitigates the potential for clindamycin-induced Propionibacterium acnes-resistant strains. New formulations may allow such regimens to be effectively used without overly reduced tolerability resulting from the irritation potential of tretinoin and BPO. This randomized, single-blind study investigated the local tolerability, irritation potential, and safety of an aqueous-based gel (clindamycin phosphate 7.2%-tretinoin 0.025% [CT gel]) when used in conjunction with a BPO wash 4% in participants with mild to moderate acne vulgaris. Participants applied the CT gel once daily in the evening for 4 weeks in conjunction with once-daily morning use of either BPO wash 4% or nonmedicated soap-free cleanser lotion (SFC). Local tolerability and irritation potential were assessed by participants and investigators using separate 6-point scales. The frequency and severity of dryness, scaling, erythema, burning/stinging, and itching increased during the first week of treatment in both treatment arms but decreased thereafter. Local tolerability reactions were slightly more frequent in the CT gel + BPO wash group versus the CT gel + SFC group at week 1 but were generally mild and improved within 1 to 2 weeks. In conclusion, therapy with CT gel + BPO wash appears safe and well-tolerated in participants with mild to moderate acne vulgaris.     

A comparison of clindamycin phosphate 1 percent topical lotion and placebo in the treatment of acne vulgaris

The efficacy and skin tolerance of 1 percent clindamycin phosphate lotion were compared with those of the placebo for the lotion in a randomized, double-blind, 12-week study in forty-six patients with moderate to severe acne vulgaris. Patients using the 1 percent clindamycin lotion experienced reductions in numbers of pustules, papules, open comedones, and nodulocystic lesions. Papule counts were also reduced in placebo-treated patients. The group using clindamycin lotion had significantly greater reductions in pustule counts at week 12 and papule counts at week 3 than the placebo-treated group. Nearly 90 percent of the evaluable patients at week 12 experienced improvement or marked improvement in their acne according to the physician's evaluation, regardless of treatment group. Both regimens were well tolerated. Although diarrhea was reported by eight patients (three taking clindamycin, five receiving placebo), no patients discontinued the protocol because of diarrhea. This study demonstrated the efficacy of 1 percent clindamycin topical lotion in the treatment of moderate to severe acne vulgaris.     

1 percent clindamycin phosphate solution versus 5 percent benzoyl peroxide gel in papulopustular acne

In a multicenter study, 60 patients suffering from mainly moderate papulopustular acne were treated to pically either with 1% clindamycin phosphate in alcoholic solution or with 5% benzoyl peroxide gel, 30 patients each. During the treatment period of 9 weeks, clinical controls with lesion counts were performed every 3 weeks and after a 3 weeks follow-up. The therapeutic efficacy according to the reduction of papules and pustules was 72% in the benzoyl peroxide group and 73% in the clindamycin group, the latter showing significantly less side effects. On account of its good therapeutic results, we consider topical treatment with clindamycin phosphate an important alternative to systemic antibiotic or topical benzoyl peroxide therapy in acne.     

Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients

Background  Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0·1% and benzoyl peroxide (BPO) 2·5% has recently been developed for the once-daily treatment of acne.
Objectives  To evaluate the efficacy and safety of adapalene 0·1%–BPO 2·5% fixed-dose combination gel (adapalene–BPO) relative to adapalene 0·1% monotherapy (adapalene), BPO 2·5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.
Methods  In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene–BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.
Results  Adapalene–BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.
Conclusions  Adapalene–BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies.     

Water-based versus alcohol-based benzoyl peroxide preparations in the treatment of acne vulgaris

Forty-eight patients with acne vulgaris in the face were treated with a water-based (Basiron) and an alcohol-based (Panoxyl) 5% benzoyl peroxide preparation. A randomized double-blind, contralateral study was used. No difference in clinical effect was found. Treatment for 8 weeks resulted in at least 50% reduction in the number of closed comedones, papules and pustules in over 80% of the patients. In more than 70% of the patients, the reduction exceeded 75%. The water-based Basiron caused significantly less skin irritation than the alcohol-based preparation of Panoxyl.     

A retrospective assessment and comparison of the effectiveness of benzoyl peroxide; the combination of topical niacinamide,gallic acid,and lauric acid; and the combination of benzoyl peroxide and erythromycin in acne vulgaris

Acne vulgaris is a chronic inflammatory skin disease that mostly develops during adolescence and continues throughout adulthood. It affects the face, the main location of cosmetic appearance. Despite many developments in acne treatment, various combination therapies are needed to create the best option. Ninety patients were included in this study. We used the global acne grading system (GAGS) and the lesion counting and photographic standards that were used by Hayashi et al., to assess acne severity. The patients were randomly divided into three groups as group 1 (using only 5% BPO, twice a day), group 2 (using only the combination of 5% BPO + 3% erythromycin, twice a day), and group 3 (using only the combination of 4% niacinamide + 1% gallic acid + 1% lauric acid, twice a day). Thirty patients were included in each group. The scores were evaluated at weeks 0, 2, 4 and 8, and compared with each other. As a result of the study, all three treatment types were found to be effective. The combination of 4% niacinamide + 1% gallic acid + 1% lauric acid can be used as an alternative topical treatment for acne vulgaris to prevent resistance against topical antibiotics and the side effects of some other treatments.     

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。     

A new drug combination for the topical treatment of acne. Miconazole 2% + benzoyl peroxide 5% versus benzoyl peroxide 5%--a double-blind study

A double-blind, controlled clinical trial with 60 patients was employed in order to study the relative merits of two treatment schedules in acne vulgaris. One therapy comprised the topical application of a cream containing a combination of miconazole 2% and benzoylperoxide 5% (Acnidazil, Janssen) twice a day. In the other therapy, we applied a cream containing only benzoylperoxide 5%. Both groups of patients showed large and statistically significant reduction in the number of comedones, papules, and pustules during 12 weeks of therapy. Acnidazil, however, was found to have definitely better therapeutical results than benzoylperoxide alone: The lesions improved significantly faster, tolerance was better, and the patients overall evaluation clearly favored Acnidazil. 86,2% of the patients treated with Acnidazil rated the results good to very good, in contrast to 63% of the patients treated with benzoylperoxide only (p = 0.037).     

Effect of sequential application of topical adapalene and clindamycin phosphate in the treatment of Japanese patients with acne vulgaris

The efficacy of combined therapy with a retinoid and antibiotic for Japanese patients with acne vulgaris remains to be established. Further, maintenance strategies limiting the use of topical retinoids must be identified. The objectives of this study are to determine the efficacy of sequential application of topical adapalene and clindamycin phosphate and to assess the impact of this regimen on patients' quality of life. Sixty-six patients were recruited. The regimen comprised two phases. For the 4-week initial treatment, 1% clindamycin phosphate gel was applied twice daily and 0.1% adapalene gel, once. In the 4-week maintenance phase, patients were randomly assigned to the OD group (adapalene applied once daily) or the TW group (adapalene applied once daily on 2 days per week). The acne severity score, lesion counts, microcomedone count, and sebum amount were measured. Quality of life (QOL) was assessed using Skindex-16. All parameters improved significantly by week 4 of initial treatment. No statistically significant differences were found in the improvement of clinical findings between the groups. All QOL scores improved significantly and did not significantly differ between the groups. Our regimen may enable clinical control of acne in Japanese patients and improve their QOL. For limiting retinoid use, weekly application of adapalene during maintenance is suitable.     

Effect of topical benzoyl peroxide/clindamycin versus topical clindamycin and vehicle in the reduction of Propionibacterium acnes

Propionibacterium acnes is one of the primary factors involved in the pathogenesis of acne vulgaris; proliferation of this bacteria is present in all patients with inflammatory lesions. Combination topical therapy with agents that have different but complementary antimicrobial mechanisms of action has the potential to increase efficacy and to prevent the emergence of resistant organisms. The onset of action and effectiveness of 3 topical preparations (benzoyl peroxide 5%/clindamycin phosphate 1% gel, clindamycin phosphate 1% solution, and vehicle gel) in reducing P acnes were compared in a randomized, open-label, evaluator-blinded, comparative trial involving 60 healthy volunteers who were free of acne but had high levels of facial P acnes. Treatment with benzoyl peroxide 5%/clindamycin phosphate 1% gel significantly (P<.001) reduced P acnes levels by >1 log10/cm2 from baseline (91% inhibition) 24 hours after application. Progressive declines were observed throughout the 2-week study period, with a 3 log10/cm2 reduction (99.9% inhibition) from baseline in P acnes at the end of the 2-week treatment period. In contrast, significant (P<.05) reductions from baseline in P acnes levels following treatment with clindamycin phosphate 1% solution were only observed at the last assessment period (2 weeks), with an average reduction of 0.64 log10/cm2 (77% inhibition). Patients receiving vehicle gel had no measurable reductions in P acnes from baseline. These results demonstrate that topical benzoyl peroxide 5%/clindamycin phosphate 1% gel produces rapid and clinically relevant reductions in P acnes greater than those produced by single-agent therapy. This activity is likely responsible for the quick onset of clinical efficacy produced by this combination regimen.