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

NCT ID: NCT02945657

Last Updated: 2018-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MM36 1% ointment

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

Group Type EXPERIMENTAL

MM36 topical ointment, 1%

Intervention Type DRUG

Twice daily application for 28 consecutive days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MM36 topical ointment, 1%

Twice daily application for 28 consecutive days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OPA-15406

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medimetriks Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noah Rosenberg, MD

Role: STUDY_DIRECTOR

Medimetriks Pharmaceuticals, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medimetriks Investigational Site

Houston, Texas, United States

Site Status

Medimetriks Investigational Site

Norfolk, Virginia, United States

Site Status

Medimetriks Investigational Site

Spokane, Washington, United States

Site Status

Medimetriks Investigational Site

San Pedro Sula, , Honduras

Site Status

Medimetriks Investigational Site

Panama City, , Panama

Site Status

Medimetriks Investigational Site

Fremont, California, United States

Site Status

Medimetriks Investigational Site

Irvine, California, United States

Site Status

Medimetriks Investigational Site

San Diego, California, United States

Site Status

Medimetriks Investigational Site

Miami, Florida, United States

Site Status

Medimetriks Investigational Site

Saint Joseph, Missouri, United States

Site Status

Medimetriks Investigational Site

Portland, Oregon, United States

Site Status

Medimetriks Investigational Site

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Honduras Panama

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEDI-MM36-206

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.