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A Study of a Whole-Body Balm on Newborn Babies

CompletedNA

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Conditions: Healthy

Interventions: Whole-body Balm, Wash and Shampoo

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 0 Days to 3 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Salt Lake City, Utah, United States