Phase 3 Completed N=364 Randomized Triple-blind Treatment

Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

Atopic Dermatitis

Source: ClinicalTrials.gov NCT03908970 ↗

Enrolled (actual)

364

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity — 38.46; 12.64 percentage of perticipants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

To demonstrate the superiority of IMP (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 adult patients with AD.

Outcome Measures

Outcome	Result	p-value
PRIMARY Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity	38.46; 12.64	—
SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score	-4.17; -0.08	—
SECONDARY Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score	-0.65; -0.04	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of AD based on the Japanese Dermatological Association's criteria
History of AD for at least 3 years
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03908970). 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.