Clinical Trial: Promiseb Topical Cream for Cradle Cap

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double Blind, Placebo-Controlled, Pilot Study to Estimate the Efficacy and Tolerability of Twice Daily Promiseb Topical Cream in Pediatric Subjects With Cradle Cap (

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.

Detailed Summary:
Sponsor: Promius Pharma, LLC

Current Primary Outcome:

• Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14). [ Time Frame: end of treatment (Day 7 or 14) ]
  IGA scored on scale of 0 (clear) to 4 (severe).
• Number of Participants With Excellent Overall Safety Score at End of Treatment. [ Time Frame: End of treatment ]
  The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).

Original Primary Outcome:

• Subjects with Investigator Global Assessment (IGA) success (IGA of 0 or 1) or failure (IGA = 2, 3, 4) at Day 7. [ Time Frame: Day 7 ]
• Overall safety score at Day 7. [ Time Frame: Days 1-7. ]
  Tolerance will be assessed by the subject's caregiver throughout the study using a study diary and discussions with the investigator at each clinic visit. All adverse events (AEs) will reported and included in the assessments. The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation; Grade 1-Slight signs of irritation which resolved; Grade 2-Clear signs of irritation; Grade 3-Patient discontinued due to irritation.
• Subjects with Investigator Global Assessment (IGA) success (IGA of 0 or 1) or failure (IGA = 2, 3, 4) at Day 14. [ Time Frame: Day 14. ]
• Overall safety score at Day 14. [ Time Frame: Days 8-14. ]
  Tolerance will be assessed by the subject's caregiver throughout the study using a study diary and discussions with the investigator at each clinic visit. All adverse events (AEs) will reported and included in the assessments. The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation; Grade 1-Slight signs of irritation which resolved; Grade 2-Clear signs of irritation; Grade 3-Patient discontinued due to irritation.

Current Secondary Outcome:

• Precent Reduction From Baseline for Scaling at End of Treatment. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]
  Scaling score on a scale of 0 (none) to 4 (severe).
• Percent Reduction From Baseline for Crusting at End of Treatment. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]
  Crusting scored on a scale of 0 (none) to 4 (severe).
• Percent Reduction From Baseline for Erythema at End of Treatment. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]
  Erythema scored on scale of 0 (none) to 4 (severe).
• Percent Reduction From Baseline for Oiliness at End of Treatment. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]
  Oiliness scored on a scale of 0 (none) to 4 (severe).

Original Secondary Outcome:

• Reduction in baseline scaling at Day 7. [ Time Frame: Day 7 ]
• Reduction in baseline crusting at Day 7. [ Time Frame: Day 7 ]
• Reduction in baseline erythema at Day 7. [ Time Frame: Day 7 ]
• Reduction in baseline oiliness at Day 7. [ Time Frame: Day 7 ]
• Reduction in baseline scaling at Day 14. [ Time Frame: Day 14 ]
• Reduction in baseline crusting at Day 14. [ Time Frame: Day 14 ]
• Reduction in baseline erythema at Day 14. [ Time Frame: Day 14 ]
• Reduction in baseline oiliness at Day 14. [ Time Frame: Day 14 ]

Dates:
Date Received: September 28, 2010
Date Started: March 2010
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017