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

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

August 21, 2017

Primary Completion Date

May 18, 2018

Study Completion Date

May 18, 2018

Conditions
Acne Vulgaris
Interventions
DRUG

DFD-03 Lotion, 0.1%

DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

DRUG

Tazorac Cream, 0.1%

Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

DRUG

DFD-03 Vehicle Lotion 0%

Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

DRUG

Tazorac Vehicle Cream 0%

Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Trial Locations (1)

33144

International Dermatology Inc., Miami

All Listed Sponsors
lead

Dr. Reddy's Laboratories Limited

INDUSTRY