A Phase 3 interventional study of OPA-15406 and Vehicle in Atopic Dermatitis (AD), sponsored by Otsuka Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in Japan. Open to participants aged 3 Months to 14 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 198 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Drug: OPA-15406
Drug: Vehicle
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
Also known as: difamilast
vehicle, topical, twice daily, for 8 weeks
Success rate in Investigator's Global Assessment (IGA)
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.
Time frame: Week 4
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Difamilast
Otsuka Pharmaceutical Co., Ltd. →