Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis - Full Text View

Sponsor:	Promius Pharma, LLC
Information provided by:	Promius Pharma, LLC
ClinicalTrials.gov Identifier:	NCT00828412

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

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: 3 and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in SCORAD [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Pruritus severity score [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Sleep disturbance score [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Investigator global assessment [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Quality of life index [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Active Comparator EpiCeram Skin Barrier Emulsion	Device: EpiCeram Skin Barrier Emulsion topical cream, twice daily, 6 weeks
2: Active Comparator 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
Genders Eligible for Study:	Both
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

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

No publications provided

Responsible Party:	Promius Pharma, LLC ( Director Clinical Operations )
Study ID Numbers:	EPC0801
Study First Received:	January 21, 2009
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00828412 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Desonide
Pharmacologic Actions
Hypersensitivity

Genetic Diseases, Inborn
Therapeutic Uses
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on February 08, 2010