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

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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.

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.

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
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Houston, Texas 77030
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Austin, Texas 78759
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Fremont, California 94538
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Irvine, California 92697
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Miami, Florida 33125
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Norfolk, Virginia 23502
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Norfolk, VA
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Portland, Oregon 97239
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Saint Joseph, Missouri 64506
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Saint Joseph, MO
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San Diego, California 92123
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San Diego, CA
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San Pedro Sula,
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Spokane, Washington 99202
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Spokane, WA
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