There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.
Mt Sinai Hospital - Dept of Dermatology
New York, New York, United States
RECRUITINGChange in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
Time frame: Weeks 2, 4, 8, 12
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Change in PIH score from baseline will be assessed. (based on a 6 point scale)
Time frame: Weeks 2, 4, 8, 12
Total number of adverse events.
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
Time frame: Weeks 2, 4, 8, 12
Change in Subject Self Assessment Scoring Scale
Patient rates current severity of their acne.
Time frame: Weeks 2, 4, 8, 12
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Acne-QoL as completed by patient.
Time frame: Weeks 2, 4, 8, 12
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