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

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