Phase 4 N=100 Randomized Single-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT00828412 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Change From Baseline in Three Item Severity Score — -2.6; -3.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: EpiCeram Skin Barrier Emulsion (Device); Desonide Cream 0.05% (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Promius Pharma, LLC
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Three Item Severity Score	-2.6; -3.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00828412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.