Phase III Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-jRCT2080224005
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
Following dermal application of JTE-052 ointment 0.25% twice daily for 4 weeks in pediatric patients with AD, the percent improvement in mEASI score at EOT was significantly greater in the 0.25% group than in the placebo group, demonstrating the superiority of the 0.25% group over the placebo group. Twice-daily application of JTE-052 ointment 0.25% or 0.5% for up to 56 weeks was safe and well tolerated in pediatric patients with AD. The improvements in AD were maintained during the treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 137
Patients diagnosed with mild, moderate or severe AD
Modified Eczema Area and Severity Index(mEASI) >=5
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
Use of topical corticosteroids (classified as strongest or very strong drugs) within 28 days before baseline
Use of topical corticosteroids (classified as strong, medium or weak drugs) or tacrolimus hydrate ointment within 7 days before baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Percent change in mEASI
- Secondary Outcome Measures
Name Time Method efficacy<br>Eczema Area and Severity Index (EASI)<br>Investigator's Global Assessment (IGA)<br>Face and Neck IGA<br>Pruritus score<br>Percent body surface area (%BSA) affected by eczema with inflammation<br>Time (in days) to dropout due to worsened target disease