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
42
topical non steroidal cream, twice daily
Eucerin cream twice daily
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
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
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)
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