A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Evaluator-Blinded, Clinical Evaluation of a Regimen of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Tolerability and Impact on Skin Barrier and Microbiome on Newborns

Conditions
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Healthy

Intervention / Treatment
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* Other: Baby Wash/Shampoo
* Other: Baby Lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Baby and Parent: Baby medically determined to be in overall good health and eligible for study participation. Parent determined to be in generally good health and able to participate fully in the study For Baby only: Healthy, full-term, newborns 0 - 28 days old at start of study, (both vaginal and Caesarean mode of delivery may be included, 37+ weeks gestation) Fitzpatrick Skin Types I - VI For Parent only: 18 years of age or older Biological, legal guardian and primary caregiver of the baby participant (must be able to present proof of guardianship [that is, birth certificate along with valid identification {ID} of parent, hospital records, insurance card, et cetera {etc.}]) Able to read, write, speak, and understand english Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure Has to have access to internet to be able to complete questionnaires and diaries Intends to successfully complete the study and is willing and able to follow the participant responsibilities Exclusion Criteria: For Baby and Parent: Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication Is taking medications that would mask an adverse event (AE) or influence the study results, including: immunosuppressive and steroidal drugs within 3 months before Visit 1 and during the study; non-steroidal anti-inflammatory drugs within 5 days before Visit 1 and during the study; antihistamines within 2 weeks before Visit 1 and during the study; systemic or topical over-the-counter (OTC) or prescription medications that, in the principle investigator (PI)'s judgement, will affect skin condition or interfere with study evaluation (example, antibiotics). Use of acetaminophen as needed is acceptable if it was instructed by the baby's pediatrician. Child vitamins are allowed Has a history of or a concurrent health condition/situation which, in the opinion of the PI, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study Is simultaneously participating in any other type of study or has participated in a study within the past 14 days Is an employee/contractor or immediate family member of the PI, study site or sponsor For Baby only: Presents with a skin condition that may influence the outcome of the study (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer) Either biological parent or a sibling has clinically determined atopic dermatitis or asthma Clinical grade greater than 0 for rash/irritation or greater or equal to 1 for any of the other clinically assessed parameters For Parent only: Is self-reported to be pregnant or planning to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baby Wash/Shampoo<br>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. | Other: Baby Wash/Shampoo<br>* Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily.<br>|
| Experimental: Baby Wash/Shampoo + Baby Lotion<br>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. | Other: Baby Wash/Shampoo<br>* Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily.<br>Other: Baby Lotion<br>* Parent participant will use the baby lotion on baby participants at least once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |