Phase III Clinical Study of JTE-052 Ointment - Long-Term Study of JTE-052 Ointment in Japanese infant Patients with Atopic Dermatitis
Phase 3
Completed
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-jRCT2080225316
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
This study confirmed that twice-daily dermal application of JTE-052 ointment 0.25% or 0.5% for 52 weeks resulted in low systemic exposure to JTE-052 and was safe and well tolerated in Japanese infant patients with atopic dermatitis. Twice-daily application of JTE- 052 ointment 0.25% or 0.5% improved atopic dermatitis in infant patients and the efficacy in improving atopic dermatitis was maintained during long-term application of JTE-052 ointment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Patients diagnosed with mild, moderate or severe atopic dermatitis
Exclusion Criteria
Active infection at the prospective application site
History of tuberculosis
Hepatitis B/C virus carriers or history of hepatitis B/C virus infection
History or presence of malignant tumor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method