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

Ceragenix Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Fluticasone Propionate 0.05%; Device: Epiceram(r)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616538

CPI 2006-002

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

121 participants in 2 patient groups

Cutivate(r)

Active Comparator group

Description:

Topical mid-strength steroid

Treatment:

Drug: Fluticasone Propionate 0.05%

EpiCeram(r)

Experimental group

Description:

EpiCeram(r) topical barrier repair cream.

Treatment:

Device: Epiceram(r)