Acne Vulgaris Clinical Trial
Official title:
A Randomized, Double-Blind, Active-Controlled 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 for 12 Weeks
A study for Subjects with mild to moderate facial acne vulgaris. 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. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.
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.
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