Phase 4
N=42
Promiseb Topical Cream for Cradle Cap
Cradle Cap · Infantile Seborrheic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01214434 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14). — 91.7; 96 percentage of participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Promiseb Topical Cream (Device); Bland emollient (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Promius Pharma, LLC
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14). |
91.7; 96 | >0.05 |
| PRIMARY Number of Participants With Excellent Overall Safety Score at End of Treatment. |
12; 25 | — |
| SECONDARY Precent Reduction From Baseline for Scaling at End of Treatment. |
58; 90 | =0.03 sig |
| SECONDARY Percent Reduction From Baseline for Crusting at End of Treatment. |
85; 78 | =0.6 |
| SECONDARY Percent Reduction From Baseline for Erythema at End of Treatment. |
74; 89 | =.24 |
| SECONDARY Percent Reduction From Baseline for Oiliness at End of Treatment. |
88; 90 | =0.8 |
Summary
The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.