A Study of a Whole-Body Balm on Newborn Babies

Johnson & Johnson (J&J)

Status: Completed

Conditions: Healthy

Treatments: Other: Whole-body Balm; Other: Wash and Shampoo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05786209

CCSSKB005124 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: Under 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Newborn participants only:

• Male or Female
• 0 to 3 months old, targeting at least 15 subjects in the 0 - 28 days age range at time of enrollment.
• Has Parent Participant-reported Natural Skin tone/skin Color As Follows, including: (a) Skin tones "Pale/fair to light white" and/or "White to light beige" approximately 10 participants; (b) Skin tones "Beige to light tan/light olive" and/or "Medium tan/medium olive to light brown" approximately 10 participants; (c) Skin tones "Medium brown to dark brown" and/or "Darkest brown to darkest black" approximately 10 participants
• Full term (37 plus weeks of gestation, both vaginal and Caesarean mode of delivery can be included) newborn

Newborn participant and parent participant:

• Generally, in good health based on medical history reported by the parent participant

Parent participant only:

• Able to read, write, speak, and understand English
• At least 18 years old and is the parent (adoptive or biological), legal guardian, and primary caregiver of the newborn participant
• Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
• Intends to complete the study and is willing and able to follow all study instructions

Exclusion criteria

Newborn participant only:

• Presents with a skin condition that may influence the outcome of the study or increase risk to the newborn participant (example , psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
• Has a family history of (defined as having a biological parent or full sibling with) eczema/atopic dermatitis
• Has been bathed within 3 hours prior to Visit 1
• Has a clinical grade greater than 0 for rash/irritation, or greater than or equal to 1 for any of the other clinically assessed tolerance parameters at Visit 1

Newborn participant and parent participant:

• Has known allergies or adverse reactions to common topical skincare products
• Has self-reported (for the parent participant) or parent participant reported (for the newborn participant) Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
• Is taking a medication that would mask an AE or confound the study results, including (a) Immunosuppressive or steroidal drugs within 3 months before Visit 1; (b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; (C) Antihistamines within 2 weeks (14 days) before Visit 1

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Whole-body Balm + Wash and Shampoo

Experimental group

Description:

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.

Treatment:

Other: Whole-body Balm

Other: Wash and Shampoo