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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Promius Pharma, LLC

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 26, 2009
Results First Submitted Date  ICMJE September 17, 2013
Results First Posted Date  ICMJE December 9, 2013
Last Update Posted Date January 30, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
Change From Baseline in Three Item Severity Score [ Time Frame: 3 and 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
  • Change from baseline in SCORAD [ Time Frame: 3 and 6 weeks ]
  • Pruritus severity score [ Time Frame: 3 and 6 weeks ]
  • Sleep disturbance score [ Time Frame: 3 and 6 weeks ]
  • Investigator global assessment [ Time Frame: 3 and 6 weeks ]
  • Quality of life index [ Time Frame: 3 and 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Device: EpiCeram Skin Barrier Emulsion
    topical cream, twice daily, 6 weeks
  • Drug: Desonide Cream 0.05%
    topical cream, twice daily, 6 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    EpiCeram Skin Barrier Emulsion
    Intervention: Device: EpiCeram Skin Barrier Emulsion
  • Active Comparator: 2
    Desonide Cream 0.05%
    Intervention: Drug: Desonide Cream 0.05%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00828412
Other Study ID Numbers  ICMJE EPC0801
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Promius Pharma, LLC
Study Sponsor  ICMJE Promius Pharma, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joanne Fraser, PhD Promius Pharma, LLC
PRS Account Promius Pharma, LLC
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP