Last updated on February 2018

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

Brief description of study

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.

Clinical Study Identifier: NCT03341910

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Javier Alonso-Llamazares, M.D.

International Dermatology Inc.
Miami, FL United States
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