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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT02945657

Run by

Medimetriks Pharmaceuticals, Inc

People needed

32

Starts

2016-10-01

Expected to finish

2017-06-08

Last updated by the study team

2018-11-19

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Medimetriks Investigational Site — Fremont, California, United States
• Medimetriks Investigational Site — Irvine, California, United States
• Medimetriks Investigational Site — San Diego, California, United States
• Medimetriks Investigational Site — Miami, Florida, United States
• Medimetriks Investigational Site — Saint Joseph, Missouri, United States
• Medimetriks Investigational Site — Portland, Oregon, United States
• Medimetriks Investigational Site — Austin, Texas, United States
• Medimetriks Investigational Site — Houston, Texas, United States
• Medimetriks Investigational Site — Norfolk, Virginia, United States
• Medimetriks Investigational Site — Spokane, Washington, United States
• Medimetriks Investigational Site — San Pedro Sula, Honduras
• Medimetriks Investigational Site — Panama City, Panama

Full record on ClinicalTrials.gov

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