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CompletedNCT00616538Updated Feb 15, 2008

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

A Phase 4 interventional study of Epiceram(r) and Fluticasone Propionate 0.05% in Atopic Dermatitis, sponsored by Ceragenix Pharmaceuticals. Completed. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2008-02-15.

Sponsored by Ceragenix Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
6 Months to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic
  • Dermatitis
  • eczema
  • skin barrier
  • ceramide
  • topical
  • inflamation
  • steroid
  • SCORAD
  • glucocorticoids
  • EpiCeram
  • Cutivate
  • fluticasone
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 121 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Ceragenix Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
121 participants (actual)

Study arms

  • Active comparator
    Cutivate(r)

    Topical mid-strength steroid

    Drug: Fluticasone Propionate 0.05%

  • Experimental
    EpiCeram(r)

    EpiCeram(r) topical barrier repair cream.

    Device: Epiceram(r)

Interventions

  • DeviceEpiceram(r)

    Topical barrier repair emulsion cream

  • DrugFluticasone Propionate 0.05%

    Topical mid-strength steroid

06

What researchers measure

Primary outcomes

  1. Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)

    Time frame: 4 weeks

Secondary outcomes

  1. Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)

    Time frame: 4 weeks

  2. Change in assessments of Pruritus and sleep habits

    Time frame: week 4

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00616538
Lead sponsor
Ceragenix Pharmaceuticals
First posted
Feb 15, 2008
Start date
Dec 2006
Primary completion
Apr 2007
Last update
Feb 15, 2008

Study contacts

Jeffrey Sugarman, MD
principal investigator · University of California, San Francisco, CA
Lawrence Parrish, MD
principal investigator · Medical College of Thomas Jefferson University, Philadelphia, PA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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