NCT01139450

Study of 0417 Ointment in the Treatment of Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 899 (actual)
• Sponsor: Fougera Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	0417	Topical 0417 test product applied twice daily for 4 weeks
DRUG	Vehicle of 0417 test product	Vehicle of 0417 test product applied twice daily for 4 weeks
DRUG	Tacrolimus Ointment 0.03%	Reference product for 0417 test product. Apply twice daily for 4 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2010-06-08
• Last updated: 2014-10-09
• Results posted: 2014-09-30

Locations

1 site across 1 country: United States