Cradle Cap Clinical Trial
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 (Seborrheic Dermatitis)
| Verified date | July 2013 |
| Source | Promius Pharma, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Derm Research | Louisville | Kentucky |
| United States | UMDNJ | Newark | New Jersey |
| United States | Norwich Pediatric Group | Norwich | Connecticut |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Promius Pharma, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14). | IGA scored on scale of 0 (clear) to 4 (severe). | end of treatment (Day 7 or 14) | No |
| Primary | Number of Participants With Excellent Overall Safety Score at 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). | End of treatment | Yes |
| Secondary | Precent Reduction From Baseline for Scaling at End of Treatment. | Scaling score on a scale of 0 (none) to 4 (severe). | end of treatment (Day 7 or 14) | No |
| Secondary | Percent Reduction From Baseline for Crusting at End of Treatment. | Crusting scored on a scale of 0 (none) to 4 (severe). | end of treatment (Day 7 or 14) | No |
| Secondary | Percent Reduction From Baseline for Erythema at End of Treatment. | Erythema scored on scale of 0 (none) to 4 (severe). | end of treatment (Day 7 or 14) | No |
| Secondary | Percent Reduction From Baseline for Oiliness at End of Treatment. | Oiliness scored on a scale of 0 (none) to 4 (severe). | end of treatment (Day 7 or 14) | No |