Tazarotene versus tazarotene plus clindamycin/benzoyl peroxide in the treatment of acne vulgaris: a multicenter, double-blind, randomized parallel-group trial

Journal of Drugs in Dermatology, March, 2006 by Emil Tanghetti, William Abramovits, Barry Solomon, Keith Loven, Alan Shalita

Discussion

It is already well documented that tazarotene offers efficacy against both non-inflammatory and inflammatory acne lesions. The results of this study confirm this and, in addition, demonstrate that the adjunctive use of a ready-to-dispense formulation of clindamycin/benzoyl peroxide gel containing 2 emollients can further enhance efficacy, and possibly tolerability. Efficacy was significantly enhanced against open plus closed comedos and, in patients with at least the median number of inflammatory lesions at baseline, against papules plus pustules. In addition to increasing efficacy, the combination regimen also promoted more rapid clinical improvement against comedos. Thus, the different mechanisms of action of clindamycin and benzoyl peroxide appear to be complementary to those of tazarotene and result in additional clinical benefit.

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The finding that the combination regimen was associated with milder grades of peeling at week 4 than monotherapy is important because the period of retinization (the first few weeks of topical retinoid therapy when the skin is accommodating to the retinoid) is the most likely time for local skin irritation to develop. So, if the potential for peeling can be reduced at this time, patients are presumably more likely to be satisfied with their treatment. Although the differences in the incidence of peeling and dryness were not statistically significant, this study was not designed to detect significant between-group differences in these parameters--as a result, it is possible that significance might be detected in a larger study.

Possible improvements in tolerability have been reported previously when topical retinoids are used in combination therapy rather than as monotherapy. In a study in which erythromycin/benzoyl peroxide was used adjunctively with tazarotene gel, the incidence of discontinuations due to adverse events was lower with tazarotene plus erythromycin/benzoyl peroxide (6%) than with tazarotene gel alone (11%). (14) Less irritation has also been reported when tretinoin is used in conjunction with benzoyl peroxide than when used alone. (15) Nevertheless, the presence of the emollients in the clindamycin/benzoyl peroxide formulation used in this study remains a likely explanation for any improvement in tolerability.

Conclusions

Tazarotene cream plus a ready-to-dispense formulation of clindamycin/benzoyl peroxide gel containing 2 emollients offers significantly greater efficacy than tazarotene cream alone. In addition, the combination regimen promotes more rapid clinical improvement against comedos and may enhance tolerability relative to tazarotene cream alone. It is possible that the emollients in the clindamycin/benzoyl peroxide formulation (dimethicone and glycerin) may help promote good tolerability.

Acknowledgments

The investigators thank all the patients in this study for their cooperation and Gill Shears, PhD, for her assistance in the development of this manuscript.

Financial Disclosures