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

Information source: Promius Pharma, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: EpiCeram Skin Barrier Emulsion (Device); Desonide Cream 0.05% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Promius Pharma, LLC

Official(s) and/or principal investigator(s):
Joanne Fraser, PhD, Study Director, Affiliation: Promius Pharma, LLC

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Three Item Severity Score

Eligibility

Minimum age: 3 Months. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

National Jewish Health, Denver, Colorado 80206, United States

Northwestern University, Chicago, Illinois 60611, United States

Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States

Dermatology Research Associates, Cincinnati, Ohio 45230, United States

University of Texas, Houston, Texas 77030, United States

Additional Information

Starting date: March 2009
Last updated: October 14, 2013

Page last updated: August 23, 2015

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