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

Johnson & Johnson Consumer Inc. (J&JCI)1 site in 1 country53 target enrollmentOctober 25, 2022

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Enrollment: 53
Locations: 1
Primary Endpoint: Change from Baseline in Parental Assessment Score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 25, 2022

End Date

June 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

Change from Baseline in Parental Assessment Score

Time Frame: Baseline (Day 0) up to Day 28

The parental assessment for the baby's skin will be performed for burning/stinging and itching on the scalp, face, arms, legs, and torso (chest and back together) on a 4-point scale of '0' (none) to '3' (severe). A decrease in scores indicates an improvement.

Change from Baseline in Clinical Assessment of Cutaneous Tolerance scores

Time Frame: Baseline (Day 0) up to Day 28

The investigator will assess baby's scalp, face, arms, legs, and torso (chest and back) globally for the following parameters (that is, dryness, redness/erythema, rash/irritation, and tactile roughness) on a 4-point scale from '0' (none) to '3' (severe). A decrease in scores indicates an improvement.