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A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris

2017-11-20 03:45:10 | BioPortfolio

Summary

A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%, Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects will be instructed to treat the entire face.

Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events. Urine pregnancy tests will be performed for all female subjects. A physical examination will be performed.

Study Design

Conditions

Acne Vulgaris

Intervention

Tazorac 0.1% Topical Cream, DFD-03 (tazarotene) Topical Lotion, 0.1%, Vehicle Cream 0%, Vehicle Lotion 0%

Location

International Dermatology Inc.
Miami
Florida
United States
33144

Status

Recruiting

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-11-20T03:45:10-0500

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