Promiseb Topical Cream for Cradle Cap

Phase 4CompletedNCT01214434

Promius Pharma, LLC42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cradle Cap Infantile Seborrheic Dermatitis

Interventions

Promiseb Topical CreamDEVICE

topical non steroidal cream, twice daily

Bland emollientOTHER

Eucerin cream twice daily

Eligibility

Sex: ALLMin age: 30 Days

Medical Language ↔ Plain English

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

Locations (4)

Norwich Pediatric Group

Norwich, Connecticut, United States

Derm Research

Louisville, Kentucky, United States

UMDNJ

Newark, New Jersey, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: End of treatment

Secondary Outcomes

Precent Reduction From Baseline for Scaling at End of Treatment.

Scaling score on a scale of 0 (none) to 4 (severe).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: From Baseline to end of treatment (Day 7 or 14)

Data from ClinicalTrials.gov

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