Clinical trial NCT05786209: A Study of a Whole-Body Balm on Newborn Babies
Official title: A Single-Center, Four Week Usage Clinical Study to Evaluate the Tolerance and Efficacy of a Whole-Body Balm on Newborn Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
timeFrame: Change from baseline after 4 weeks
Secondary outcomes:
measure: Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures
timeFrame: Change from baseline after 7 days
measure: Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
timeFrame: Change from baseline after 7 days
measure: Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
timeFrame: Change from baseline after 4 weeks
measure: Number of Response Options for Each Question in the Parental Questionnaire
timeFrame: Day 28
measure: Percentage of All Response Options for Each Question in the Parental Questionnaire
timeFrame: Day 28
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: CenExcel JBR
state: Utah
Study officials:
affiliation: CenExel JBR
name: Todd Bertoch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: https://www.courage-khazaka.de/en/scientific-products/all-products/16-wissenschaftliche-produkte/alle-produkte/183-corneometer-e.