A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
NCT02094235 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2025-06-04
Summary
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
Conditions
Interventions
- DRUG
-
E6005 0.05%
- DRUG
-
0.5 g placebo ointment
- DRUG
-
E6005 0.2%
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-12-31
- Completion
- 2015-01-31
Countries
- Japan
Study Locations
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