Clinical trial NCT05589038: A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns
Official title: A Randomized, Evaluator-Blinded, Clinical Evaluation of a Regimen of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Tolerability and Impact on Skin Barrier and Microbiome on Newborns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 53
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate the tolerance of a baby wash/shampoo alone and the tolerance of a regimen of a baby wash/shampoo and baby lotion in a newborn population.


Eligibility criteria: Inclusion Criteria:

For Baby and Parent:

* Baby medically determined to be in overall good health and eligible for study participation. Parent determined to be in generally good health and able to participate fully in the study

For Baby only:

* Healthy, full-term, newborns 0 - 28 days old at start of study, (both vaginal and Caesarean mode of delivery may be included, 37+ weeks gestation)
* Fitzpatrick Skin Types I - VI

For Parent only:

* 18 years of age or older
* Biological, legal guardian and primary caregiver of the baby participant (must be able to present proof of guardianship \[that is, birth certificate along with valid identification {ID} of parent, hospital records, insurance card, et cetera {etc.}\])
* Able to read, write, speak, and understand english
* Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
* Has to have access to internet to be able to complete questionnaires and diaries
* Intends to successfully complete the study and is willing and able to follow the participant responsibilities

Exclusion Criteria:

For Baby and Parent:

* Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials
* Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
* Is taking medications that would mask an adverse event (AE) or influence the study results, including: immunosuppressive and steroidal drugs within 3 months before Visit 1 and during the study; non-steroidal anti-inflammatory drugs within 5 days before Visit 1 and during the study; antihistamines within 2 weeks before Visit 1 and during the study; systemic or topical over-the-counter (OTC) or prescription medications that, in the principle investigator (PI)'s judgement, will affect skin condition or interfere with study evaluation (example, antibiotics). Use of acetaminophen as needed is acceptable if it was instructed by the baby's pediatrician. Child vitamins are allowed
* Has a history of or a concurrent health condition/situation which, in the opinion of the PI, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Is simultaneously participating in any other type of study or has participated in a study within the past 14 days
* Is an employee/contractor or immediate family member of the PI, study site or sponsor

For Baby only:

* Presents with a skin condition that may influence the outcome of the study (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
* Either biological parent or a sibling has clinically determined atopic dermatitis or asthma
* Clinical grade greater than 0 for rash/irritation or greater or equal to 1 for any of the other clinically assessed parameters

For Parent only:

* Is self-reported to be pregnant or planning to become pregnant during the study

Primary outcomes:
measure: Change from Baseline in Clinical Assessment of Cutaneous Tolerance scores
timeFrame: Baseline (Day 0) up to Day 28
measure: Change from Baseline in Parental Assessment Score
timeFrame: Baseline (Day 0) up to Day 28
Secondary outcomes:
measure: Change from Baseline in Microbiome
timeFrame: Baseline (Day 0) up to Day 28
measure: Change from Baseline in Metabolome
timeFrame: Baseline (Day 0) up to Day 28
measure: Change from Baseline in Skin pH
timeFrame: Baseline (Day 0) up to Day 28
measure: Change from Baseline in Parentype Questionnaire
timeFrame: Baseline (Day 0) up to Day 28
measure: Weekly Diary Compliance
timeFrame: Day 1 through Day 28
measure: Product Questionnaire as Assessed by Parent Participants
timeFrame: Day 28
Other outcomes:
Locations:
city: Newtown Square
country: United States
facility: KGL Skin Study Center, LLC
state: Pennsylvania
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Walters RM, Mao G, Gunn ET, Hornby S. Cleansing formulations that respect skin barrier integrity. Dermatol Res Pract. 2012;2012:495917. doi: 10.1155/2012/495917. Epub 2012 Aug 13.
citation: Telofski LS, Morello AP 3rd, Mack Correa MC, Stamatas GN. The infant skin barrier: can we preserve, protect, and enhance the barrier? Dermatol Res Pract. 2012;2012:198789. doi: 10.1155/2012/198789. Epub 2012 Sep 4.
citation: Capone KA, Friscia DL, Nikolovski J, Telofski LS, Stamatas GN. A randomized clinical study on the effects of emollient use on the developing infant skin microbiome and metabolome. Exp Dermatol. 2023 Jan;32(1):75-77. doi: 10.1111/exd.14684. Epub 2022 Oct 20. No abstract available.
citation: Avi Sadeh, D. Sc., Jodi A. Mindell, Ph.D., and Liat Tikotzky, Ph.D. Brief Infant Sleep Questionnaire - Revised Long Form, version January 2020