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Principal Investigator and sponsor agreed to termination.
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study.
Location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will be asked to complete the daily diary for each day of the study.
Visit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days.
Visit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CeraVe Baby Diaper Rash Cream | Experimental | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. |
|
| Desitin Maximum Strength Original Paste | Experimental | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraVe Baby Diaper Rash Cream | Drug | Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group. | For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physician Assessment Diaper Dermatitis Scores to Day 7 | For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Department of Der,matology, Feinberg School of Medicine, Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2991 | United States | ||
| Northwestern University Department of Dermatology |
Arms are combined for overall number of participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Arms are combined for overall number of baseline participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.
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| ID | Title | Description |
|---|---|---|
| BG000 | CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group. | For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared. | Study was terminated prior to analysis due to low enrollment. | Posted | 14 days |
|
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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 | CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Arms are combined for reporting of adverse events. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dermatology CTU | Northwestern University | 312-503-5944 | NUdermatologyCTU@northwestern.edu |
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| ID | Term |
|---|---|
| D003963 | Diaper Rash |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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|
|
| Desitin Maximum Strength Original Paste | Drug | Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. |
|
|
| Parents/Caregivers Daily Scores Through Duration of the Study Period |
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level |
| 14 days |
| Assessment of Tolerability by the Infant | Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level | 14 days |
| Parent/Caregiver Rating of Satisfaction With Use of the Product | Parents/caregivers will be given a questionnaire rating the use of the study products. | 14 days |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Lurie Children's Hospital Outpatient Clinic at Lincoln Park | Chicago | Illinois | 60614 | United States |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Change in Physician Assessment Diaper Dermatitis Scores to Day 7 | For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared. | Study was terminated prior to analysis due to low enrollment. | Posted | 7 days |
|
|
| Secondary | Parents/Caregivers Daily Scores Through Duration of the Study Period | Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level | Study was terminated prior to analysis due to low enrollment. | Posted | 14 days |
|
|
| Secondary | Assessment of Tolerability by the Infant | Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level | Study was terminated prior to analysis due to low enrollment. | Posted | 14 days |
|
|
| Secondary | Parent/Caregiver Rating of Satisfaction With Use of the Product | Parents/caregivers will be given a questionnaire rating the use of the study products. | Study was terminated prior to analysis due to low enrollment. | Posted | 14 days |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |