Atopic Dermatitis
Conditions
Interventions
Once daily topical application of thin layer of JTE-061 cream 0.5% to all affected areas (except the hairy scalp)
Sponsors
Yamane Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese patients aged 3 months to < 24 months 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
Exclusion criteria
Exclusion criteria: 1. Patients with a current significant skin or inflammatory condition that, in the opinion of the investigator or subinvestigator, 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 or current cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >= 75% improvement in EASI score from Baseline at Week 8 | — |
Contacts
Public Contactinformation clinical trials
Shionogi & Co.,Ltd.
Outcome results
None listed