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

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ClinicalTrials.gov Identifier: NCT00828412
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : December 9, 2013
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Desonide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Three Item Severity Score [ Time Frame: Baseline to 6 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT00828412     History of Changes
Other Study ID Numbers: EPC0801
First Posted: January 26, 2009    Key Record Dates
Results First Posted: December 9, 2013
Last Update Posted: January 30, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Decanoic acid
Desonide
Emollients
Antifungal Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Dermatologic Agents