Phase III Clinical Study of JTE-052 - Randomized Controlled and Long-term Extension Study in Patients with Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic dermatitis

• Registration Number: JPRN-jRCT2080223499
• Lead Sponsor: Japan Tobacco Inc.

Brief Summary

ollowing dermal application of JTE-052 ointment 0.5% twice daily for 4 weeks in patients with atopic dermatitis, the percent improvement in mEASI score at the EOT was significantly greater in the JTE-052 ointment 0.5% group than in the placebo group, demonstrating the superiority of the JTE-052 ointment 0.5% group over the placebo group. This study confirmed that dermal application of JTE-052 ointment 0.5% twice daily for 28 weeks was safe and well tolerated in Japanese patients with atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-31
• Study Completion: 2018-09-14
• Results First Posted: 2020-02-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Patients with moderate or severe atopic dermatitis
-Modified Eczema Area and Severity Index (mEASI) >=10

Exclusion Criteria

Patients with active infection at the study drug application site
Use of topical corticosteroids (strongest or very strong) within 28 days before baseline
Use of topical corticosteroids (strong, medium or weak) within 7 days before baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified