Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis

Medimetriks Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: MM36 topical ointment, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02945657

MEDI-MM36-206

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

MM36 1% ointment

Experimental group

Description:

MM36 topical ointment, 1%, applied twice daily for 28 days

Treatment:

Drug: MM36 topical ointment, 1%