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The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promiseb Topical Cream | Experimental |
| |
| Bland emollient | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promiseb Topical Cream | Device | topical non steroidal cream, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | End of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Precent Reduction From Baseline for Scaling at End of Treatment. | Scaling score on a scale of 0 (none) to 4 (severe). | From Baseline to end of treatment (Day 7 or 14) |
| Percent Reduction From Baseline for Crusting at End of Treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne M Fraser, PhD | Promius Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwich Pediatric Group | Norwich | Connecticut | 06360 | United States | ||
| Derm Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bland Emollient | Bland emollient : Eucerin cream twice daily |
| FG001 | Promiseb Topical Cream | Promiseb Topical Cream : topical non steroidal cream, twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bland Emollient | Bland emollient : Eucerin cream twice daily |
| BG001 | Promiseb Topical Cream | Promiseb Topical Cream : topical non steroidal cream, twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Number | percentage of participants | end of treatment (Day 7 or 14) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bland Emollient | Bland emollient : Eucerin cream twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strep throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Small number of subjects enrolled and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Center | Promius Pharma, LLC | 888 966-8766 | product-complaints@promiuspharma.com |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| C537005 | Complement component 5 deficiency |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Bland emollient |
| Other |
Eucerin cream twice daily |
|
Crusting scored on a scale of 0 (none) to 4 (severe).
| 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). | 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). | From Baseline to end of treatment (Day 7 or 14) |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| UMDNJ | Newark | New Jersey | 07101 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Site error |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Promiseb Topical Cream : topical non steroidal cream, twice daily
|
|
|
| Primary | 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). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Number | participants | End of treatment |
|
|
|
| Secondary | Precent Reduction From Baseline for Scaling at End of Treatment. | Scaling score on a scale of 0 (none) to 4 (severe). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Mean | Standard Deviation | percent reduction from baseline | From Baseline to end of treatment (Day 7 or 14) |
|
|
|
|
| Secondary | Percent Reduction From Baseline for Crusting at End of Treatment. | Crusting scored on a scale of 0 (none) to 4 (severe). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Mean | Standard Deviation | percent reduction from baseline | From Baseline to end of treatment (Day 7 or 14) |
|
|
|
|
| Secondary | Percent Reduction From Baseline for Erythema at End of Treatment. | Erythema scored on scale of 0 (none) to 4 (severe). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Mean | Standard Deviation | percent reduction from baseline | From Baseline to end of treatment (Day 7 or 14) |
|
|
|
|
| Secondary | Percent Reduction From Baseline for Oiliness at End of Treatment. | Oiliness scored on a scale of 0 (none) to 4 (severe). | All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data. | Posted | Mean | Standard Deviation | percent reduction from baseline | From Baseline to end of treatment (Day 7 or 14) |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Promiseb Topical Cream | Promiseb Topical Cream : topical non steroidal cream, twice daily | 0 | 25 | 0 | 25 |
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| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |