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

• 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: Promius Pharma, LLC
• Information provided by (Responsible Party): Promius Pharma, LLC

Tracking Information

• First Submitted Date: January 21, 2009
• First Posted Date: January 26, 2009
• Results First Submitted Date: September 17, 2013
• Results First Posted Date: December 9, 2013
• Last Update Posted Date: January 30, 2017
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 23, 2009): Change From Baseline in Three Item Severity Score [ Time Frame: 3 and 6 weeks ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Device: EpiCeram Skin Barrier Emulsion
  topical cream, twice daily, 6 weeks
• Drug: Desonide Cream 0.05%
  topical cream, twice daily, 6 weeks

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2009): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00828412
• Other Study ID Numbers: EPC0801
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Promius Pharma, LLC
• Study Sponsor: Promius Pharma, LLC
• Collaborators: Not Provided

Investigators

• Study Director: Joanne Fraser, PhD; Promius Pharma, LLC

• PRS Account: Promius Pharma, LLC
• Verification Date: December 2016