Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis

Ceragenix Pharmaceuticals121 enrolled

Overview

Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

121

Conditions

Atopic Dermatitis

Interventions

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages \> 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study * Males or Females * Age: 6 months to 18 years * Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index Exclusion Criteria: * Subjects with mild AD as defined by the Rajka-Laneland Severity Index. * Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%) * Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study. * Subjects who require greater than 2mg per day of inhaled or intranasal steroids. * Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month. * Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil. * Active infection of any type at the start of the study.

Outcomes

Primary Outcomes

Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)

Time frame: 4 weeks

Secondary Outcomes

Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)

Time frame: 4 weeks

Change in assessments of Pruritus and sleep habits

Time frame: week 4