Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tazarotene 0.1% gel plus clindamycin 1% gel; Adapalene 0.1% gel plus clindamycin 1% gel
Intervention type(s): Drug; Drug
Intervention description(s): Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and tazarotene will be applied 5-10 minutes later.; Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and adapalene will be applied 5-10 minutes later.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tazarotene; Adapalene; Clindamycin