NCT03341910

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-05-18
• Completion: 2018-05-18
• First posted: 2017-11-14
• Last updated: 2020-08-17
• Results posted: 2020-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study