A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: E6005 0.2%; Drug: Placebo; Drug: E6005 0.05%

• Registration Number: NCT02094235
• Lead Sponsor: Dermavant Sciences GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	E6005 0.2%	E6005 0.2% ointment applied twice a day to eczema areas
3	Placebo	Placebo ointment applied twice a day to eczema areas
2	E6005 0.05%	E6005 0.05% ointment applied twice a day to eczema areas

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of E6005	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	Up to 21 Days	The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in severity score of targeted eczema	Baseline and Day 15	For targeted eczema defined at baseline, intensity of 4 symptoms (erythema, infiltration/papulation, excoriation, and lichenification) will be assessed using a 5-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) (maximal score: 16).
Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites	Baseline and Day 15	Severity of AD dermal symptoms in targeted eczema and whole application sites wil be assessed based on a 6-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe, 5: most severe).
Change from Baseline in intensity of pruritus	Baseline and Day 15	1) Interview-based pruritus scores: Subjects or caregivers (who must not be changed throughout the study) will assess the intensity of pruritus day and night within 3 days before the visit. 2) Investigator-assessed pruritus: The investigator will assess pruritus conditions by grading into 5 levels (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) based on the comprehensive judgments of interview and scratching behaviors.