Atopic Dermatitis (AD)
Conditions
Brief summary
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
Interventions
DRUGOPA-15406
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
DRUGVehicle
vehicle, topical, twice daily, for 8 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
* Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association) * Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations * Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Exclusion criteria
* Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination * Participants who have been treated with OPA-15406 ointment in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in Investigator's Global Assessment (IGA) | Week 4 | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. |
Countries
Japan
Contacts
Primary ContactDrug Information Center
Outcome results
None listed