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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC
ClinicalTrials.gov Identifier:
NCT00828412
First received: January 21, 2009
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Device: EpiCeram Skin Barrier Emulsion
Drug: Desonide Cream 0.05%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Promius Pharma, LLC:

Primary Outcome Measures:
  • Change From Baseline in Three Item Severity Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
EpiCeram Skin Barrier Emulsion
Device: EpiCeram Skin Barrier Emulsion
topical cream, twice daily, 6 weeks
Active Comparator: 2
Desonide Cream 0.05%
Drug: Desonide Cream 0.05%
topical cream, twice daily, 6 weeks

  Eligibility

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828412

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Dermatology Research Associates
Cincinnati, Ohio, United States, 45230
United States, Texas
University of Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
Study Director: Joanne Fraser, PhD Promius Pharma, LLC
  More Information

No publications provided

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT00828412     History of Changes
Other Study ID Numbers: EPC0801
Study First Received: January 21, 2009
Results First Received: September 17, 2013
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desonide
Decanoic acid
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 20, 2014