Promiseb Topical Cream for Cradle Cap
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01214434|
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : November 20, 2013
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cradle Cap Infantile Seborrheic Dermatitis||Device: Promiseb Topical Cream Other: Bland emollient||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
|Experimental: Promiseb Topical Cream||
Device: Promiseb Topical Cream
topical non steroidal cream, twice daily
|Sham Comparator: Bland emollient||
Other: Bland emollient
Eucerin cream twice daily
- Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14). [ Time Frame: end of treatment (Day 7 or 14) ]IGA scored on scale of 0 (clear) to 4 (severe).
- Number of Participants With Excellent Overall Safety Score at End of Treatment. [ Time Frame: 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).
- Precent Reduction From Baseline for Scaling at End of Treatment. [ Time Frame: 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 Crusting at End of Treatment. [ Time Frame: 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. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]Erythema scored on scale of 0 (none) to 4 (severe).
- Percent Reduction From Baseline for Oiliness at End of Treatment. [ Time Frame: From Baseline to end of treatment (Day 7 or 14) ]Oiliness scored on a scale of 0 (none) to 4 (severe).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214434
|United States, Connecticut|
|Norwich Pediatric Group|
|Norwich, Connecticut, United States, 06360|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Joanne M Fraser, PhD||Promius Pharma|