Acne Vulgaris Clinical Trial
Official title:
Comparison of Safety and Efficacy of Tazarotene 0.1% Plus Clindamycin 1% Gel vs. Adapalene 0.1% Plus Clindamycin 1% Gel in the Treatment of Facial Acne Vulgaris: A Randomized Controlled Trial
The combination therapy of retinoid and clindamycin for acne is preferred because it targets multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby improving outcome. Literature review reveals that till date there is no published comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus clindamycin. So the present study has been designed to compare these two combination therapy in acne vulgaris.
Acne vulgaris is one of the most common disorders treated by dermatologists. The
pathogenesis of acne is multifactorial. Critical components include abnormal follicular
keratinocyte desquamation leading to the formation of a follicular plug (microcomedo),
increase of sebum production in pilosebaceous unit, colonization by Propionibacterium acnes,
and inflammation. Topical retinoids, which target comedogenesis and have anti-inflammatory
activity, are recommended as first-line therapy for both inflammatory and non-inflammatory
acne. The adjunctive use of anti-acne agents like clindamycin by its complementary mechanism
of action can help to enhance the efficacy of topical retinoid therapy still further.
Tazarotene is a synthetic retinoid and a prodrug that is converted by the skin to its active
form, tazarotenic acid. The active form binds to retinoic acid receptors (RARs) and
regulates gene transcription and helps to normalize the abnormal keratinization in the
follicular infundibulum, this in turn changes the microenvironment of the follicle and
thereby reduce the proliferation of Propionibacterium acnes. Adapalene is a synthetic
naphthoic acid derivative with retinoid activity. Adapalene also acts through RARs and
modulates cellular keratinization and inflammatory process. Clindamycin is bactericidal to
Propionibacterium acnes. Due to the inhibition of P. acnes the free fatty acid levels in the
pilosebaceous unit of skin is also reduced. Clindamycin phosphate applied topically
penetrates to a very great extent to open comedones and thus produces a high percentage of
sterile comedones.
The combination therapy of retinoid and clindamycin for acne is preferred because it targets
multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby
improving outcome. Literature review reveals that till date there is no published
comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene
plus clindamycin. So the present study has been designed to compare these two combination
therapy in acne vulgaris.
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