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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Promius Pharma, LLC

ClinicalTrials.gov Identifier:

NCT00828412

First received: January 21, 2009

Last updated: December 1, 2016

Last verified: December 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Device: EpiCeram Skin Barrier Emulsion Drug: Desonide Cream 0.05%	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: atopic dermatitis

MedlinePlus related topics: Eczema

Drug Information available for: Desonide

U.S. FDA Resources

Further study details as provided by Promius Pharma, LLC:

Primary Outcome Measures:

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.


Enrollment:	100
Study Start Date:	March 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	3 Months to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828412

Locations


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

Sponsors and Collaborators

Promius Pharma, LLC

Investigators


Study Director:	Joanne Fraser, PhD	Promius Pharma, LLC

More Information


Responsible Party:	Promius Pharma, LLC
ClinicalTrials.gov Identifier:	NCT00828412 History of Changes
Other Study ID Numbers:	EPC0801
Study First Received:	January 21, 2009
Results First Received:	September 17, 2013
Last Updated:	December 1, 2016

Additional relevant MeSH terms:


Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity	Immune System Diseases Desonide Emollients Decanoic acid Anti-Inflammatory Agents Dermatologic Agents Antifungal Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017

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