Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2031230139
- Lead Sponsor
- Yamane Satoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Japanese patients aged between 2 and 11 years at informed consent who can visit the study site as an outpatient
2. Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
3. Patients whose IGA score, EASI score, and %BSA affected meet the criteria specified in the study protocol
1. Patients with a history of or current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
2. Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella) skin infection within 1 week prior to Week 0
3. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
4. Patients with serious concomitant disease(s)
5. Patients with a history of or current cancer within 5 years prior to screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method