Last updated on February 2018

A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks


Brief description of study

Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any severity on the chest and/or back (including shoulders) may be enrolled provided they have mild to moderate acne on the face. During the 12-week treatment period subjects will use the study product twice daily with approximately 12 hours between applications. Subjects will be instructed to treat the entire face (and chest/back including shoulders, if applicable).

Co-Primary efficacy endpoints include:

  • Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
  • Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
  • Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.

The primary safety endpoint will be treatment-emergent adverse events (TEAEs). Other safety variables include local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). Urine pregnancy tests will be performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination will be performed at the Baseline Visit.

Clinical Study Identifier: NCT03292640

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Sunil Dhawan, M.D.

Center for Dermatology Clinical Research Inc.
Fremont, CA United States
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