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Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EpiCeram Skin Barrier Emulsion
Desonide Cream 0.05%
Sponsored by
Promius Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 3 months of age and less than 13 years of age
  • atopic dermatitis of moderate severity

Exclusion Criteria:

  • pregnant or lactating
  • treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
  • treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
  • serious or uncontrolled medical condition
  • active infection
  • significant use of inhaled, intranasal, or intraocular corticosteroid

Sites / Locations

  • National Jewish Health
  • Northwestern University
  • Wake Forest University Health Sciences
  • Dermatology Research Associates
  • University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

EpiCeram Skin Barrier Emulsion

Desonide Cream 0.05%

Outcomes

Primary Outcome Measures

Change From Baseline in Three Item Severity Score
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2009
Last Updated
December 1, 2016
Sponsor
Promius Pharma, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00828412
Brief Title
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Official Title
A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promius Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
EpiCeram Skin Barrier Emulsion
Arm Title
2
Arm Type
Active Comparator
Arm Description
Desonide Cream 0.05%
Intervention Type
Device
Intervention Name(s)
EpiCeram Skin Barrier Emulsion
Intervention Description
topical cream, twice daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Desonide Cream 0.05%
Intervention Description
topical cream, twice daily, 6 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Three Item Severity Score
Description
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 3 months of age and less than 13 years of age atopic dermatitis of moderate severity Exclusion Criteria: pregnant or lactating treatment of atopic dermatitis with topical product in the 14 days prior to Baseline treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline serious or uncontrolled medical condition active infection significant use of inhaled, intranasal, or intraocular corticosteroid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Fraser, PhD
Organizational Affiliation
Promius Pharma, LLC
Official's Role
Study Director
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Dermatology Research Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

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