Phase 2
Completed N=73
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03018691 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: The Number of Subjects Experiencing AEs — 11; 14; 12 participants
Summary
To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects Experiencing AEs |
11; 14; 12 | — |
| SECONDARY Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4 |
37.50; 40.00; 8.33 | — |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score |
-5.33; -5.52; 0.56 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score |
-18.00; -17.21; 8.19 | — |
| SECONDARY Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score |
-0.83; -0.73; 0.30 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score |
-4.33; -4.37; 2.26 | — |
| SECONDARY Change From Baseline in Percentage Affected Body Surface Area |
-6.06; -8.21; 1.78 | — |
| SECONDARY Mean (SD) OPA-15406 Plasma Trough Concentrations at week1 |
0.842; 2.90 | — |
| SECONDARY Mean (SD) OPA-15406 Plasma Trough Concentrations at week4 |
0.946; 2.21 | — |
| SECONDARY Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week1 |
0.196; 0.210 | — |
| SECONDARY Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week4 |
0.150; 0.166 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Exclusion Criteria
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Data sourced from ClinicalTrials.gov (NCT03018691). 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.