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| ID | Type | Description | Link |
|---|---|---|---|
| CCSSKB005013 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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Study terminated due to project timelines.
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The purpose of this study is to demonstrate the tolerance of a baby wash/shampoo alone and the tolerance of a regimen of a baby wash/shampoo and baby lotion in a newborn population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baby Wash/Shampoo | Experimental | Parent participant will bathe the baby participants using baby wash/shampoo at least 3 times per week, but no more than once daily, up to 4 weeks. |
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| Baby Wash/Shampoo + Baby Lotion | Experimental | Parent participant will bathe the baby participants using baby wash/shampoo at least 3 times per week, but no more than once daily, and apply lotion at least once daily after bathing, for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby Wash/Shampoo | Other | Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Clinical Assessment of Cutaneous Tolerance scores | The investigator will assess baby's scalp, face, arms, legs, and torso (chest and back) globally for the following parameters (that is, dryness, redness/erythema, rash/irritation, and tactile roughness) on a 4-point scale from '0' (none) to '3' (severe). A decrease in scores indicates an improvement. | Baseline (Day 0) up to Day 28 |
| Change from Baseline in Parental Assessment Score | The parental assessment for the baby's skin will be performed for burning/stinging and itching on the scalp, face, arms, legs, and torso (chest and back together) on a 4-point scale of '0' (none) to '3' (severe). A decrease in scores indicates an improvement. | Baseline (Day 0) up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Microbiome | Change in microbiome samples as analyzed in laboratory will be reported. | Baseline (Day 0) up to Day 28 |
| Change from Baseline in Metabolome | Change in metabolome samples as analyzed in laboratory will be reported. |
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Inclusion Criteria:
For Baby and Parent:
For Baby only:
For Parent only:
Exclusion Criteria:
For Baby and Parent:
For Baby only:
For Parent only:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial | Johnson & Johnson Consumer Inc. (J&JCI) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL Skin Study Center, LLC | Newtown Square | Pennsylvania | 19073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22927835 | Background | Walters RM, Mao G, Gunn ET, Hornby S. Cleansing formulations that respect skin barrier integrity. Dermatol Res Pract. 2012;2012:495917. doi: 10.1155/2012/495917. Epub 2012 Aug 13. | |
| 22988452 | Background | Telofski LS, Morello AP 3rd, Mack Correa MC, Stamatas GN. The infant skin barrier: can we preserve, protect, and enhance the barrier? Dermatol Res Pract. 2012;2012:198789. doi: 10.1155/2012/198789. Epub 2012 Sep 4. |
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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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| Baby Lotion | Other | Parent participant will use the baby lotion on baby participants at least once daily. |
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| Baseline (Day 0) up to Day 28 |
| Change from Baseline in Skin pH | Change from baseline in skin pH will be reported. | Baseline (Day 0) up to Day 28 |
| Change from Baseline in Parentype Questionnaire | Parentype questionnaire will be completed by the participant's parent. The six axes will be calculated based on parent's responses on well-being, adaptiveness, parental identity, resilience, sense of ease and parental confidence in intuition and the average will be reported. | Baseline (Day 0) up to Day 28 |
| Weekly Diary Compliance | The parent participants will be contacted by the site via a phone call visit to complete a weekly diary. Weekly diary compliance will be assessed as follows: Usage compliance for 1 week will include 3 times usage for the Baby Wash/Shampoo and 7 time usage for the Baby Lotion per week. 90 percent (%) compliance would be about 2 time usage misses for the baby wash/shampoo in 28 days, and 3 time usage misses for the Baby lotion. | Day 1 through Day 28 |
| Product Questionnaire as Assessed by Parent Participants | Product questionnaire will be completed by the parent participants which include the question about "how much do you agree or disagree after using the baby wash/shampoo and baby lotion routine" where 1 indicates "strongly disagree", 2 indicates "somewhat disagree", 3 indicates "neither agree/disagree, 4 indicates "somewhat agree", and 5 indicate "strongly agree". | Day 28 |
| 36204776 | Background | Capone KA, Friscia DL, Nikolovski J, Telofski LS, Stamatas GN. A randomized clinical study on the effects of emollient use on the developing infant skin microbiome and metabolome. Exp Dermatol. 2023 Jan;32(1):75-77. doi: 10.1111/exd.14684. Epub 2022 Oct 20. No abstract available. |
| Background | Avi Sadeh, D. Sc., Jodi A. Mindell, Ph.D., and Liat Tikotzky, Ph.D. Brief Infant Sleep Questionnaire - Revised Long Form, version January 2020 |