Promiseb Topical Cream for Cradle Cap

Phase 4

Completed

• Conditions: Cradle Cap; Infantile Seborrheic Dermatitis
• Interventions: Other: Bland emollient; Device: Promiseb Topical Cream

• Registration Number: NCT01214434
• Lead Sponsor: Promius Pharma, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-07-08
• Results First Submitted QC: 2013-09-17
• Results First Posted: 2013-11-20
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bland emollient	Bland emollient	-
Promiseb Topical Cream	Promiseb Topical Cream	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Excellent Overall Safety Score at End of Treatment.	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).
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).	end of treatment (Day 7 or 14)	IGA scored on scale of 0 (clear) to 4 (severe).

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Derm Research; 🇺🇸 Louisville, Kentucky, United States

Norwich Pediatric Group; 🇺🇸 Norwich, Connecticut, United States

UMDNJ; 🇺🇸 Newark, New Jersey, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States