A Study of a Whole-Body Balm on Newborn Babies

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT05786209

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

28

Starts

2023-03-27

Expected to finish

2023-10-06

Last updated by the study team

2024-03-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CenExcel JBR — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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