Phase 2
Completed N=32
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT02945657 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of MM36 — 23.1 ng/mL
Summary
The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of MM36 |
16.9 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration (Tmax) of MM36 |
3.80 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 |
86.2 | — |
| SECONDARY Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
24; 7; 0 | — |
| SECONDARY Treatment-Emergent Adverse Events (AEs) According to Severity |
24; 6; 1; 0 | — |
| SECONDARY Application Site Adverse Events (AEs) |
29; 1; 1 | — |
| SECONDARY Application Site Adverse Events (AEs) According to Severity |
29; 1; 1; 0 | — |
| SECONDARY Clinically Meaningful Laboratory Test Median Changes From Baseline |
— | — |
| SECONDARY Clinically Meaningful Vital Sign Median Changes From Baseline |
— | — |
| SECONDARY Clinically Meaningful ECG Median Changes From Baseline to Day 15 |
— | — |
| SECONDARY Clinically Meaningful ECG Median Changes From Baseline to Day 29 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects 2 to <18 years of age
- Diagnosis of atopic dermatitis (AD)
- AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)
Exclusion Criteria
- Active or acute viral skin infection
- History of recurrent bacterial infection
- Malignancy
- Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
Data sourced from ClinicalTrials.gov (NCT02945657). 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.