Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment
Overview
- Phase
- Phase 3
- Intervention
- 0417
- Conditions
- Atopic Dermatitis
- Sponsor
- Fougera Pharmaceuticals Inc.
- Enrollment
- 899
- Locations
- 1
- Primary Endpoint
- Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of Atopic Dermatitis
- •Good health with the exception of Atopic Dermatitis
- •Percent Body Surface Area minimum requirements
Exclusion Criteria
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
Arms & Interventions
Test
Test product that contains the active pharmaceutical ingredient
Intervention: 0417
Reference
Reference product that contains the active pharmaceutical ingredient
Intervention: Tacrolimus Ointment 0.03%
Vehicle
Placebo that contains no active pharmaceutical ingredient
Intervention: Vehicle of 0417 test product
Outcomes
Primary Outcomes
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
Time Frame: 4 weeks
Secondary Outcomes
- The Mean Change From Baseline in Pruritus(Baseline, 4 weeks)
- The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region(Baseline, 4 weeks)
- The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)(Baseline, 4 weeks)