Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 2 - 17 |
Updated: | 11/21/2018 |
Start Date: | October 2016 |
End Date: | June 8, 2017 |
Protocol MEDI-MM36-206: A Phase 2 Multi-center, Open-label Study to Assess Pharmacokinetic Parameters and Safety of Topical MM36 (1%) in Pediatric Subjects 2 to < 18 Years of Age With Atopic Dermatitis Under Maximal Use Conditions
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.
MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use
conditions.
This is a multi-center, open-label study to assess the degree of systemic exposure and safety
of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in
pediatric subjects with atopic dermatitis.
of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in
pediatric subjects with atopic dermatitis.
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
We found this trial at
11
sites
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