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| ID | Type | Description | Link |
|---|---|---|---|
| CCSSKB005124 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and perceived product efficacy of a whole-body balm on newborns (0-28 days old).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body Balm + Wash and Shampoo | Experimental | Parent participant will be instructed to apply the whole-body balm on the newborn baby's whole body (excluding the mouth, eyes, diaper area, and scalp) two times per day (morning and evening), and to cleanse the newborn baby with the wash and shampoo at least once per week and no more than three times per week up to Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-body Balm | Other | Balm will be applied to cover newborn's entire body (while avoiding the mouth, eyes, diaper area, and scalp), and gently massaged onto the skin until the balm is fully absorbed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures | Change from baseline after 4 weeks of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation. | Change from baseline after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures | Change from baseline after 7 days of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation. | Change from baseline after 7 days |
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Inclusion Criteria:
Newborn participants only:
Newborn participant and parent participant:
Parent participant only:
Exclusion Criteria:
Newborn participant only:
Newborn participant and parent participant:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, M.D. | Cenexel JBR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExcel JBR | Salt Lake City | Utah | 84107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | https://www.courage-khazaka.de/en/scientific-products/all-products/16-wissenschaftliche-produkte/alle-produkte/183-corneometer-e. |
| Label | URL |
|---|---|
| Redacted CSR Synopsis with Disclaimer | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Wash and Shampoo | Other | Wash and shampoo will be used to cleanse newborn baby using an "in tub" bathing method. |
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| Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements | Change from baseline after 7 days of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface. | Change from baseline after 7 days |
| Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements | Change from baseline after 4 weeks of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface. | Change from baseline after 4 weeks |
| Number of Response Options for Each Question in the Parental Questionnaire | Number of response options for each question in the parental questionnaire will be reported. Parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'. | Day 28 |
| Percentage of All Response Options for Each Question in the Parental Questionnaire | Percentage of all response options for each question in the parental questionnaire will be reported. parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'. | Day 28 |
| D008919 |
| Investigative Techniques |