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

Johnson & Johnson (J&J)

Status: Terminated

Conditions: Healthy

Treatments: Other: Baby Lotion; Other: Baby Wash/Shampoo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05589038

CCSSKB005013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Baby Wash/Shampoo

Experimental group

Description:

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.

Treatment:

Other: Baby Wash/Shampoo

Baby Wash/Shampoo + Baby Lotion

Experimental group

Description:

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.

Treatment:

Other: Baby Wash/Shampoo

Other: Baby Lotion