Clinical trial NCT00616538: Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic
Dermatitis
eczema
skin barrier
ceramide
topical
inflamation
steroid
SCORAD
glucocorticoids
EpiCeram
Cutivate
fluticasone
Lead sponsor: Ceragenix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 121
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)
timeFrame: 4 weeks
measure: Change in assessments of Pruritus and sleep habits
timeFrame: week 4
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco, CA
name: Jeffrey Sugarman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Thomas Jefferson University, Philadelphia, PA
name: Lawrence Parrish, MD
role: PRINCIPAL_INVESTIGATOR
References: