Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

December 1, 2016 updated by: Promius Pharma, LLC

A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis

This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45230
        • Dermatology Research Associates
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 3 months of age and less than 13 years of age
  • atopic dermatitis of moderate severity

Exclusion Criteria:

  • pregnant or lactating
  • treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
  • treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
  • serious or uncontrolled medical condition
  • active infection
  • significant use of inhaled, intranasal, or intraocular corticosteroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
EpiCeram Skin Barrier Emulsion
Device: EpiCeram Skin Barrier Emulsion
topical cream, twice daily, 6 weeks
Active Comparator: 2
Desonide Cream 0.05%
Drug: Desonide Cream 0.05%
topical cream, twice daily, 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Three Item Severity Score
Time Frame: Baseline to 6 weeks
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Promius Pharma, LLC

Investigators

  • Study Director: Joanne Fraser, PhD, Promius Pharma, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPC0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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