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

• Status: Completed
• Trial end date: 2017-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medimetriks Pharmaceuticals, Inc

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