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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616538

Enrollment

121

Registered

2008-02-15

Start date

2006-12-31

Completion date

Unknown

Last updated

2008-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid, SCORAD, glucocorticoids, EpiCeram, Cutivate, fluticasone

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.

Interventions

DEVICEEpiceram(r)

Topical barrier repair emulsion cream

DRUGFluticasone Propionate 0.05%

Topical mid-strength steroid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)	4 weeks

Secondary

Measure	Time frame
Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)	4 weeks
Change in assessments of Pruritus and sleep habits	week 4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026