A Study of a Whole-Body Balm on Newborn Babies

NCT05786209 | Completed

• 1 other identifier: CCSSKB005124
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures

  Change from baseline after 4 weeks of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.

  Change from baseline after 4 weeks

Secondary Outcomes (5)

• Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures

  Change from baseline after 7 days

• Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements

  Change from baseline after 7 days

• Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements

  Change from baseline after 4 weeks

• Number of Response Options for Each Question in the Parental Questionnaire

  Day 28

• Percentage of All Response Options for Each Question in the Parental Questionnaire

  Day 28

Study Arms (1)

Whole-body Balm + Wash and Shampoo

EXPERIMENTAL

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.

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

Interventions

Whole-body Balm OTHER

Balm will be applied to cover newborn's entire body (while avoiding the mouth, eyes, diaper area, and scalp), and gently massaged onto the skin until the balm is fully absorbed.

Whole-body Balm + Wash and Shampoo

Wash and Shampoo OTHER

Wash and shampoo will be used to cleanse newborn baby using an "in tub" bathing method.

Whole-body Balm + Wash and Shampoo

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn participants only:
• Male or Female
• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

CenExcel JBR

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• https://www.courage-khazaka.de/en/scientific-products/all-products/16-wissenschaftliche-produkte/alle-produkte/183-corneometer-e.

  BACKGROUND

Related Links

• Redacted CSR Synopsis with Disclaimer

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Todd Bertoch, M.D.

  Cenexel JBR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: March 27, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)