NCT01053247

Study of 0416 Ointment in the Treatment of Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 793 (actual)
• Sponsor: Fougera Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	0416	Topical 0416 test product applied twice daily for 2 weeks
DRUG	Vehicle of 0416 test product	Vehicle of 0416 test product applied twice daily for 2 weeks
DRUG	tacrolimus ointment 0.1%	Reference Product for 0416 test product. Apply twice daily for 2 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2010-01-21
• Last updated: 2014-10-03
• Results posted: 2014-10-03

Locations

1 site across 1 country: United States