Promiseb Topical Cream for Cradle Cap

Overview

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

Full Title of Study: “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 (Seborrheic Dermatitis)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2011

Interventions

  • Device: Promiseb Topical Cream
    • topical non steroidal cream, twice daily
  • Other: Bland emollient
    • Eucerin cream twice daily

Arms, Groups and Cohorts

  • Experimental: Promiseb Topical Cream
  • Sham Comparator: Bland emollient

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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).

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of cradle cap – Must be at least 30 days old – Must be in good health as determined by investigator – Naive to prior cradle cap therapy (may have used mineral, olive oils) Exclusion Criteria:

  • Known food, topical product or medicinal allergies. – Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap – Weighing less than 7 lbs

Gender Eligibility: All

Minimum Age: 30 Days

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Promius Pharma, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joanne M Fraser, PhD, Study Director, Promius Pharma

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