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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Unnamed facility
Chitose-shi, Hokkaido, Japan
Unnamed facility
Eniwa-shi, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Pharmacokinetics of E6005
The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit
Time frame: Up to 21 Days
Number of participants with adverse events as a measure of the safety and tolerability of E6005
The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.
Time frame: Up to 21 Days
Change from Baseline in severity score of targeted eczema
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).
Time frame: Baseline and Day 15
Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites
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).
Time frame: Baseline and Day 15
Change from Baseline in intensity of pruritus
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.
Time frame: Baseline and Day 15
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