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A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris

2017-09-25 03:52:15 | BioPortfolio

Summary

Enrollment of subjects with mild to moderate facial acne. Subjects with 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. Subjects will be instructed to treat the entire face (and chest and/or back including shoulders, if applicable).

Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12.

Safety assessments will include the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching; assessed separately on the chest and/or back including shoulders (if applicable), vital signs (blood pressure and pulse rate), and adverse events (AEs). 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.

Study Design

Conditions

Acne Vulgaris

Intervention

DFD-03

Location

Dr. Seemal
Plano
Texas
United States
75024

Status

Recruiting

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-25T03:52:15-0400

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