Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
Information source: Ceragenix Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: Epiceram(r) (Device); Fluticasone Propionate 0.05% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ceragenix Pharmaceuticals Official(s) and/or principal investigator(s):
Jeffrey Sugarman, MD, Principal Investigator, Affiliation: University of California, San Francisco, CA
Lawrence Parrish, MD, Principal Investigator, Affiliation: Medical College of Thomas Jefferson University, Philadelphia, PA
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
Primary outcome: Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
Secondary outcome: Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)Change in assessments of Pruritus and sleep habits
Eligibility
Minimum age: 6 Months.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: December 2006
Last updated: February 5, 2008
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