A PhaseII Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis
Phase 2
Completed
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-jRCT2080223498
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
The efficacy and safety of JTE-052 ointment were confirmed in pediatric patients with atopic dermatitis. The results supported either dose of 0.25% or 0.5% as the clinically recommended dose of JTE-052 ointment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
Patients with atopic dermatitis
Modified Eczema Area and Severity Index(mEASI) >=5
Exclusion Criteria
Patients with active infection
Patients with history of tuberculosis
Patients with hepatitis B/C virus carriers or history of hepatitis B/C virus infection
Patients with history or presence of malignant tumor
Use of topical corticosteroids (strongest or very strong) within 28 days before baseline
Use of topical corticosteroids (strong, medium or weak) or tacrolimus hydrate ointment within 7 days before baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method