Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment

NCT01139450 Phase 3 COMPLETED Results posted

The aim of this trial is to assess the efficacy of 0417 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 4 weeks.

Details

Lead sponsor	Fougera Pharmaceuticals Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	899
Start date	2008-01
Completion	2009-08

Conditions

• Atopic Dermatitis

Interventions

• 0417
• Vehicle of 0417 test product
• Tacrolimus Ointment 0.03%

Primary outcomes

• Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment — 4 weeks

Countries

United States