A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns

October 5, 2023 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Newtown Square, Pennsylvania, United States, 19073
        • KGL Skin Study Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baby Wash/Shampoo
Parent participant will bathe the baby participants using baby wash/shampoo at least 3 times per week, but no more than once daily, up to 4 weeks.
Other: Baby Wash/Shampoo
Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily.
Experimental: Baby Wash/Shampoo + Baby Lotion
Parent participant will bathe the baby participants using baby wash/shampoo at least 3 times per week, but no more than once daily, and apply lotion at least once daily after bathing, for 4 weeks.
Other: Baby Wash/Shampoo
Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily.
Other: Baby Lotion
Parent participant will use the baby lotion on baby participants at least once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0) up to Day 28
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.
Baseline (Day 0) up to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Microbiome
Time Frame: Baseline (Day 0) up to Day 28
Change in microbiome samples as analyzed in laboratory will be reported.
Baseline (Day 0) up to Day 28
Change from Baseline in Metabolome
Time Frame: Baseline (Day 0) up to Day 28
Change in metabolome samples as analyzed in laboratory will be reported.
Baseline (Day 0) up to Day 28
Change from Baseline in Skin pH
Time Frame: Baseline (Day 0) up to Day 28
Change from baseline in skin pH will be reported.
Baseline (Day 0) up to Day 28
Change from Baseline in Parentype Questionnaire
Time Frame: Baseline (Day 0) up to Day 28
Parentype questionnaire will be completed by the participant's parent. The six axes will be calculated based on parent's responses on well-being, adaptiveness, parental identity, resilience, sense of ease and parental confidence in intuition and the average will be reported.
Baseline (Day 0) up to Day 28
Weekly Diary Compliance
Time Frame: Day 1 through Day 28
The parent participants will be contacted by the site via a phone call visit to complete a weekly diary. Weekly diary compliance will be assessed as follows: Usage compliance for 1 week will include 3 times usage for the Baby Wash/Shampoo and 7 time usage for the Baby Lotion per week. 90 percent (%) compliance would be about 2 time usage misses for the baby wash/shampoo in 28 days, and 3 time usage misses for the Baby lotion.
Day 1 through Day 28
Product Questionnaire as Assessed by Parent Participants
Time Frame: Day 28
Product questionnaire will be completed by the parent participants which include the question about "how much do you agree or disagree after using the baby wash/shampoo and baby lotion routine" where 1 indicates "strongly disagree", 2 indicates "somewhat disagree", 3 indicates "neither agree/disagree, 4 indicates "somewhat agree", and 5 indicate "strongly agree".
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

  • Study Director: Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial, Johnson & Johnson Consumer Inc. (J&JCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CCSSKB005013 (Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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