Trial intelligence / Profile preview

Epiceram vs Elidel in Pediatric Atopic Dermatitis

NCT00460083Phase 4

Key facts

Status: Completed
Start: Apr 2007
Primary completion: Dec 2007
Countries: 1
Sponsor: Ceragenix Pharmaceuticals, Inc.
Modality: Transdermal Patches, Hydrogel Systems, Small Molecules

Drugs: EpiCeram
Conditions: atopic dermatitis (AD)

Overview

Phase 4, randomised, double-blind trial of EpiCeram in atopic dermatitis (AD) (2 arms), sponsored by Ceragenix Pharmaceuticals, Inc. Primary endpoint: Eczema Area and Severity Index at 4 weeks. Started Apr 2007; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Epiceram
Epiceram barrier repair cream
Elidel
Elidel (pimecrolimus 1%) cream

Who it enrols

Pediatric subjects (2-12 years) with mild to moderate atopic dermatitis (Rajka-Langeland Severity Index).

Endpoints

Primary

Eczema Area and Severity Index4 weeks

Secondary

Investigator's Global Assessment4 weeks
Skin Capacitance4 weeks
Transepidermal Water Loss4 weeks
Pruritus Visual Analog Scale4 weeks
Children's Dermatitis Life Quality Index4 weeks

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