INTRODUCTION: A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin. OBJECTIVES: To compare the efficacy and safety of a 1% clindamycin/zinc gel when applied to the face once daily or twice daily with a 1% clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris. METHODS: This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acne patients. RESULTS: The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes. CONCLUSION: The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients.
RCT Entities:
INTRODUCTION: A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin. OBJECTIVES: To compare the efficacy and safety of a 1% clindamycin/zinc gel when applied to the face once daily or twice daily with a 1% clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris. METHODS: This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acnepatients. RESULTS: The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes. CONCLUSION: The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acnepatients.