Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Jewish Health, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EpiCeram Skin Barrier Emulsion

Device

topical cream, twice daily, 6 weeks

Desonide Cream 0.05%

Drug

topical cream, twice daily, 6 weeks

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Promius Pharma, LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 26, 2009
Registry last updated: Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed