The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
303
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Medical Corporation Kojinkai Asanuma Dermatology Clinic
Hokkaido, Japan
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 2 weeks
Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 1 weeks
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time frame: Baseline and 2 weeks
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).
Time frame: Week 2
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