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

January 21, 2009
October 14, 2013
March 2009
August 2009   (final data collection date for primary outcome measure)
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.
Change from baseline in three item severity score [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828412 on ClinicalTrials.gov Archive Site
Not Provided
  • Change from baseline in SCORAD [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Pruritus severity score [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Sleep disturbance score [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Investigator global assessment [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Quality of life index [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Device: EpiCeram Skin Barrier Emulsion
    topical cream, twice daily, 6 weeks
  • Drug: Desonide Cream 0.05%
    topical cream, twice daily, 6 weeks
  • 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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
3 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828412
EPC0801
No
Promius Pharma, LLC
Promius Pharma, LLC
Not Provided
Study Director: Joanne Fraser, PhD Promius Pharma, LLC
Promius Pharma, LLC
October 2013

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