This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Same as above.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Applied once daily at bedtime
Applied once daily in the morning
Center for Dermatology and Laser Surgery
Sacramento, California, United States
Derm Research, P.L.L.C.
Louisville, Kentucky, United States
Brodell Medical
Warren, Ohio, United States
Northwest Cutaneous Research Specialists
Portland, Oregon, United States
Percent Change From Baseline in Total Lesion Counts
Time frame: 6 and 12 weeks
Global Severity Assessment Success
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Time frame: 6 and 12 weeks
Global Assessment of Improvement From Baseline
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Erythema
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Scaling
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Dryness
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Burning/Stinging
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
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Time frame: 12 weeks