Phase 3
Completed N=251
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03911401 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity — 44.58; 47.06; 18.07 percentage of participants
◆ Published Evidence
Established
65citations · ~16 / year
Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial.
Summary
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
Linked Publications
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Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity |
44.58; 47.06; 18.07 | — |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score |
-4.97; -6.07; 0.35 | — |
| SECONDARY Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score |
-0.80; -0.68; -0.33 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of AD based on the Japanese Dermatological Association's criteria
- Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
- IGA score of 2 or 3 at the screening and baseline examinations
Exclusion Criteria
- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Data sourced from ClinicalTrials.gov (NCT03911401) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.