Trial | NCT00616538  Report issue

Title

Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    121
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 Started
Dec 31
2006
Primary Completion
Apr 30
2007
Last Update
Feb 15
2008
Estimate

Device Epiceram(r)

Topical barrier repair emulsion cream

Drug Fluticasone Propionate 0.05%

Topical mid-strength steroid

Cutivate(r) Active Comparator

Topical mid-strength steroid

EpiCeram(r) Experimental

EpiCeram(r) topical barrier repair cream.

Criteria 

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.
No Results Posted