Study of 0416 Ointment in the Treatment of Atopic Dermatitis
Phase 3
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT01053247
- Lead Sponsor
- Fougera Pharmaceuticals Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 793
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test 0416 Test product that contains the active pharmaceutical ingredient Reference tacrolimus ointment 0.1% Reference product that contains active pharmaceutical ingredient Vehicle Vehicle of 0416 test product Placebo that contains no active pharmaceutical ingredient
- Primary Outcome Measures
Name Time Method Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment 2 weeks
- Secondary Outcome Measures
Name Time Method The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA). 2 weeks
Trial Locations
- Locations (1)
Fougera Pharmaceuticals Inc.
🇺🇸Melville, New York, United States