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

Promius Pharma, LLC5 sites in 1 country100 target enrollmentMarch 2009

ConditionsAtopic Dermatitis

InterventionsEpiCeram Skin Barrier Emulsion Desonide Cream 0.05%

DrugsDesonide Cream 0.05%

Overview

Phase: Phase 4
Intervention: EpiCeram Skin Barrier Emulsion
Conditions: Atopic Dermatitis
Sponsor: Promius Pharma, LLC
Enrollment: 100
Locations: 5
Primary Endpoint: Change From Baseline in Three Item Severity Score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

August 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Promius Pharma, LLC

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1

EpiCeram Skin Barrier Emulsion

Intervention: EpiCeram Skin Barrier Emulsion

2

Desonide Cream 0.05%

Intervention: Desonide Cream 0.05%

Outcomes

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.