A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 62
- Primary Endpoint
- Pharmacokinetics of E6005
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 2 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
E6005 0.2% ointment applied twice a day to eczema areas
Intervention: E6005 0.2% (Drug)
2
E6005 0.05% ointment applied twice a day to eczema areas
Intervention: E6005 0.05% (Drug)
3
Placebo ointment applied twice a day to eczema areas
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of E6005
Time Frame: Up to 21 Days
The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit
Number of participants with adverse events as a measure of the safety and tolerability of E6005
Time Frame: Up to 21 Days
The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.
Secondary Outcomes
- Change from Baseline in severity score of targeted eczema(Baseline and Day 15)
- Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites(Baseline and Day 15)
- Change from Baseline in intensity of pruritus(Baseline and Day 15)