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.     

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.     

Tazarotene 0.1 percent cream plus clindamycin 1 percent gel versus tretinoin 0.025 percent gel plus clindamycin 1 percent gel in the treatment of facial acne vulgaris

Topical retinoids are the cornerstone of therapy for acne vulgaris. Nevertheless, the adjunctive use of other anti-acne agents can help enhance the efficacy of topical retinoids still further. Given that tazarotene 0.1 percent gel has previously shown significantly greater efficacy than tretinoin 0.025 percent gel, it is likely that tazarotene plus clindamycin offers superior efficacy to tretinoin plus clindamycin, which has recently become available as a combination product. A total of 150 patients with facial acne vulgaris were randomly assigned to receive either tazarotene 0.1 percent cream plus clindamycin 1 percent gel, or tretinoin 0.025 percent gel plus clindamycin 1 percent gel. Each medication was applied once daily in the evening (clindamycin followed by the retinoid 5-10 minutes later) for up to 12 weeks. At week 12, the reduction from baseline in lesion counts was greater with tazarotene/clindamycin than tretinoin/clindamycin for both the non-inflammatory lesion count (71% vs. 52%, p< or =.01) and the inflammatory lesion count (77% vs. 67%, P=.053). Tazarotene/clindamycin also resulted in a significantly higher incidence of patients achieving > or = 50 percent global improvement (incidence of 88% vs. 75% at week 12; p< or =.05). Both regimens were similarly well tolerated. In the treatment of facial acne vulgaris, tazarotene plus clindamycin offers significantly greater efficacy than tretinoin plus clindamycin and has comparable tolerability.     

A multicentre, single-blind, randomized comparison of a fixed clindamycin phosphate/tretinoin gel formulation (Velac) applied once daily and a clindamycin lotion formulation (Dalacin T) applied twice daily in the topical treatment of acne vulgaris

BACKGROUND: A successful phase III pilot study compared the efficacy and safety of a fixed clindamycin 1%/tretinoin 0.025% gel formulation (CTG; Velac gel) applied once daily and a clindamycin 1% lotion formulation (CLN; Dalacin T lotion) applied twice daily in the treatment of moderate to severe acne vulgaris. OBJECTIVES: We aimed to follow up this study. METHODS: The two treatment regimens were compared in a multicentre, single-blind, randomized 12-week investigation of patients with moderate to severe acne vulgaris. RESULTS: At week 12, the mean percentage reduction in non-inflamed lesions (open and closed comedones) was greater in the CTG group compared with the CLN group (P = 0.05). Absolute reductions in open and closed comedones were also greater in the CTG group, consistent with the comedolytic activity of tretinoin. There was a significantly greater absolute reduction in inflamed lesions (pustules, papules and nodules) from baseline to both end-point (last observed efficacy outcome; P = 0.043) and week 12 (P = 0.018) in the CTG group compared with the CLN group. Evaluation of the calculated overall acne severity score, considering all five lesion subtypes, demonstrated a significantly greater mean percentage reduction in the CTG group compared with the CLN group, both at end-point (P = 0.01) and at week 12 (P < 0.01). The more subjective assessment of overall acne severity according to the Cook scale also demonstrated a significantly greater mean reduction in the CTG group than the CLN group after 12 weeks of therapy (P = 0.007). CTG had a more rapid effect on the onset of improvement compared with CLN; a 50% reduction in total lesion counts by day 60 was found in 77% of patients on CTG compared with 56% receiving CLN (P = 0.003). This was largely due to the reduction in open comedone counts (P = 0. 0006). For all other variables, CTG was at least as effective as CLN. Both treatments were well tolerated. CONCLUSIONS: A single daily topical application of Velac gel was superior to Dalacin T lotion applied twice daily in reducing overall acne scores, and was faster acting. The simpler dosing regimen of Velac gel and its rapid effect are likely to have a positive effect on both patient compliance and cost.     

Comparative evaluation of clindamycin phosphate 1% and clindamycin phosphate 1% with nicotinamide gel 4% in the treatment of acne vulgaris

Eighty patients with moderate acne vulgaris were enrolled from out-patient department for the comparative evaluation of clindamycin phosphate 1% and clindamycin phosphate 1% with nicotinamide gel 4%. In group I forty patients were given clindamycin phosphate 1% alone.ln group II forty patients were given clindamycin phosphate 1% and nicotinamide gel 4% in combination. The study did not show any added advantage of clindamycin phosphate 1% in combination with nicotinamide gel 4% over clindamycin phosphate 1% alone.     

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.     

Efficacy of the fixed 1.2% clindamycin phosphate, 0.025% tretinoin gel formulation (Velac®) and a proprietary 0.025% tretinoin gel formulation (Aberela®) in the topical control of facial acne

Background A formulation containing agents affecting the non-inflammatory as well as the inflammatory lesions of acne vulgaris at the same time would be efficient, probably showing a high efficacy and possibly a considerable shortening of the duration of treatment. One single formulation would simplify drug administration thereby enhancing patient compliance and possibly leading to improved therapeutic results. In two studies this seems to have been corroborated for the fixed clindamycin phosphate-tretinoin gel formulation. Objective This study was designed to assess whether the recently developed fixed formulation of 1.2% clindamycin phosphate and 0.025% tretinoin in a gel base (Velac®), further referred to as Clindamycin phosphate Tretinoin Gel is at least as effective as a proprietary 0.025% tretinoin gel formulation (Aberela®, Janssen Cilag Ab, Sollentuna, Sweden; further defined as tretinoin) showing an additional anti-inflammatory effect in the treatment of moderate to severe acne vulgaris. Methods In a double-blind, randomised study 72 patients were treated with CTG and 73 with tretinoin gel in a once daily regimen for 12 weeks. Responses, irritation as well as possible systemic and other adverse effects were recorded after 4, 8 and 12 weeks of treatment and the improvement, compared to baseline, assessed in all included patients. An additional assessment of the safety parameters was carried out at week 2. Parameters of efficacy were the various acne lesion counts, the overall acne severity grade and the calculated totals of acne lesion counts. Results CTG was statistically significantly more effective than tretinoin at the P= 0.05 level in the papular and the total mean inflammatory lesion counts as well as in the estimated or calculated mean overall acne severity scores. CTG and tretinoin gel were equally effective in the remaining parameters: open and closed comedones, the calculated total mean comedone, the pustule as well as the nodule lesion counts. The onset of action was faster for CTG than for tretinoin gel and evident in all assessed parameters except in open comedone lesion counts. In the calculated total mean acne lesion counts, half of all acne lesions had disappeared by week 6 of treatment with CTG, whereas this was recorded at week 9 for tretinoin gel. No clinically relevant changes in the parameters of safety as a consequence of treatment were observed, although the burning component of irritation was shown to be significantly less for CTG than for tretinoin gel. The observed adverse effects were considered minor. Treatment had to be discontinued in five patients on CTG and three on tretinoin. Conclusion The addition of clindamycin to tretinoin, as in CTG, enhances the comedolytic efficacy of tretinoin in moderate to severe acne of the face, maintaining at the same time its anti-inflammatory efficacy thus accelerating resolution of all types of acne lesions without affecting the safety of response to both components.     

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.     

Treatment of acne vulgaris with clindamycin phosphate in dermatologic practice

In an open study, 34 male and 16 female patients suffering from mild up to severe acne vulgaris were treated with topical clindamycin-phosphate over a period of 8 weeks. In the course of treatment, 96% of the patients showed improvement. In 52% of the cases, at least 65% of the inflammatory eruptions faded or they disappeared altogether; 44% of the cases showed reduction of 30-65% of their lesions. Only 4% of the patients did not respond at all to the treatment. Separate study on the various degrees of severity of the disease revealed greater improvement of severe acne than with mild and moderate forms. On the basis of pathophysiology, these cases might be still more successfully treated by means of combined therapy with comedolytics.     

The unwanted effects of clindamycin in acne

A review of seventy matched acne patients on clindamycin and seventy-two on tetracycline shows that nine patients on clindamycin had diarrhoea whereas no patients on tetracycline had any side effect; no frank pseudomembranous colitis was seen. Although we heed the side effects of clindamycin, it should not be withheld from patients with severe and resistant acne.     

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.     

Potential hazards of clindamycin in acne therapy.

In the course of the last two years, a tremendous amount of controversy has been raised over dangers accompanying the use of the antibiotic clindamycin. The controversy has been stimulated by recent reports of fatalities from pseudomembraneous colitis associated with clindamycin therapy. Varying greatly in degree of severity, the colitis has been reported in as high as 10% of all patients using the drug. The pertinence of such data, however, in a young, healthy acne population receiving small maintenance doses is questionable. Nevertheless, because of these reports, the use of clindamycin in the treatment of many of the conditions for which it was previously considered indicated, including acne, is being seriously reevaluated.     

Topical clindamycin therapy for acne vulgaris. A cooperative clinical study

Eleven institutions participated in an eight-week controlled clinical study to evaluate treatment of acne vulgaris with topical clindamycin hydrochloride and clindamycin phosphate. Three hundred fifty-eight patients with comparable baseline pustule, papule, and nodule counts applied 1%, clindamycin hydrochloride, 1% clindamycin phosphate, or a hydroalcoholic vehicle twice daily. Every two weeks, lesions were counted, and patients' evaluations of their acne conditions were scored. By week 8, pustule and papule counts in the groups who were receiving clindamycin were significantly lower than those in the group receiving placebo. Also, more patients who were receiving clindamycin thought their acne improved by week 8 (with significantly higher change-in-acne scores) than did the patients receiving placebo. Patients receiving clindamycin reported 12 episodes of diarrhea; only one episode was considered to be treatment related. These results substantiate the clinical impression that topical clindamycin is effective treatment for acne.     

A clinical trial comparing the safety and efficacy of a topical erythromycin-zinc formulation with a topical clindamycin formulation

One hundred three patients with acne vulgaris were randomly designated to receive either a topical formulation of erythromycin plus zinc or a topical solution of 1% clindamycin phosphate (Cleocin-T). The patients treated themselves twice daily and were examined at 3, 6, 9, and 12 weeks after the start of therapy. By week 6 the overall severity grade was consistently lower and the percent reduction of severity, papules, pustules, and total comedones was higher in the erythromycin-zinc-treated group than in the clindamycin-treated group. In the 92 patients who completed this study (48 receiving erythromycin-zinc and 44 receiving clindamycin), no serious topical or systemic side effects were reported. Two patients, one from each treatment group, suffered mild irritation. One patient was withdrawn from the erythromycin-zinc-treated group. Results of patch tests were negative. The superiority of the erythromycin-zinc formulation may be due to the increased (4%) erythromycin concentration and/or the ability of 1.2% zinc acetate to enhance the product's activity.     

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.