Promiseb Topical Cream for Cradle Cap

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

Official Title
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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)

Conditions
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Cradle Cap, Infantile Seborrheic Dermatitis

Intervention / Treatment
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* Device: Promiseb Topical Cream
* Other: Bland emollient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Promiseb Topical Cream<br> | Device: Promiseb Topical Cream<br>* topical non steroidal cream, twice daily<br>|
| Sham Comparator: Bland emollient<br> | Other: Bland emollient<br>* Eucerin cream twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precent Reduction From Baseline for Scaling at End of Treatment. | Scaling score on a scale of 0 (none) to 4 (severe). | From Baseline to end of treatment (Day 7 or 14) | 
| Percent Reduction From Baseline for Crusting at End of Treatment. | Crusting scored on a scale of 0 (none) to 4 (severe). | From Baseline to end of treatment (Day 7 or 14) | 
| Percent Reduction From Baseline for Erythema at End of Treatment. | Erythema scored on scale of 0 (none) to 4 (severe). | From Baseline to end of treatment (Day 7 or 14) | 
| Percent Reduction From Baseline for Oiliness at End of Treatment. | Oiliness scored on a scale of 0 (none) to 4 (severe). | From Baseline to end of treatment (Day 7 or 14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cradle Cap, Infantile seborrheic Dermatitis