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

Promius Pharma, LLC100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Atopic Dermatitis

Interventions

EpiCeram Skin Barrier EmulsionDEVICE

topical cream, twice daily, 6 weeks

Desonide Cream 0.05%DRUG

topical cream, twice daily, 6 weeks

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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 (5)

National Jewish Health

Denver, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Dermatology Research Associates

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Change From Baseline in Three Item Severity Score

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.

Time frame: Baseline to 6 weeks

Data from ClinicalTrials.gov

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