Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02721173|
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Tazarotene 0.1% gel plus clindamycin 1% gel Drug: Adapalene 0.1% gel plus clindamycin 1% gel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Experimental: Tazarotene group
This group will receive tazarotene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Drug: Tazarotene 0.1% gel plus clindamycin 1% gel
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.
Active Comparator: Adapalene group
This group will receive adapalene 0.1% gel plus clindamycin 1% gel for 4 weeks.
Drug: Adapalene 0.1% gel plus clindamycin 1% gel
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.
- The number of facial acne lesions [ Time Frame: Change from baseline over 4 weeks ]Total number of facial acne lesions (inflammatory and non-inflammatory) will be counted
- Severity of acne [ Time Frame: Change from baseline over 4 weeks ]Severity of acne will be assessed by Acne global severity scale
- Severity of acne [ Time Frame: Change from baseline over 4 weeks ]Severity of acne will be assessed by Investigator's static global assessment (ISGA) score
- Quality of life [ Time Frame: Change from baseline over 4 weeks ]Quality of life will be assessed by Acne-specific quality of life questionnaire (Acne-QoL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721173
|Bhubaneswar, Odisha, India, 751019|
|Study Director:||DEBASISH HOTA, DM||AIIMS, Bhubaneswar|