Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

NCT01053247 Phase 3 COMPLETED Results posted

The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.

Details

Lead sponsor	Fougera Pharmaceuticals Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	793
Start date	2008-01
Completion	2009-08

Conditions

• Atopic Dermatitis

Interventions

• 0416
• Vehicle of 0416 test product
• tacrolimus ointment 0.1%

Primary outcomes

• Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment — 2 weeks

Countries

United States