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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Epiceram(r)
Fluticasone Propionate 0.05%
Sponsored by
Ceragenix Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid, SCORAD, glucocorticoids, EpiCeram, Cutivate, fluticasone

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Cutivate(r)

    EpiCeram(r)

    Arm Description

    Topical mid-strength steroid

    EpiCeram(r) topical barrier repair cream.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)
    Change in assessments of Pruritus and sleep habits

    Full Information

    First Posted
    February 5, 2008
    Last Updated
    February 5, 2008
    Sponsor
    Ceragenix Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00616538
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ceragenix Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis
    Keywords
    Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid, SCORAD, glucocorticoids, EpiCeram, Cutivate, fluticasone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cutivate(r)
    Arm Type
    Active Comparator
    Arm Description
    Topical mid-strength steroid
    Arm Title
    EpiCeram(r)
    Arm Type
    Experimental
    Arm Description
    EpiCeram(r) topical barrier repair cream.
    Intervention Type
    Device
    Intervention Name(s)
    Epiceram(r)
    Intervention Description
    Topical barrier repair emulsion cream
    Intervention Type
    Drug
    Intervention Name(s)
    Fluticasone Propionate 0.05%
    Intervention Description
    Topical mid-strength steroid
    Primary Outcome Measure Information:
    Title
    Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)
    Time Frame
    4 weeks
    Title
    Change in assessments of Pruritus and sleep habits
    Time Frame
    week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey Sugarman, MD
    Organizational Affiliation
    University of California, San Francisco, CA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lawrence Parrish, MD
    Organizational Affiliation
    Medical College of Thomas Jefferson University, Philadelphia, PA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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