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

NCT05589038 | Terminated

• 1 other identifier: CCSSKB005013
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Clinical Assessment of Cutaneous Tolerance scores

  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

  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 Outcomes (6)

• Change from Baseline in Microbiome

  Baseline (Day 0) up to Day 28

• Change from Baseline in Metabolome

  Baseline (Day 0) up to Day 28

• Change from Baseline in Skin pH

  Baseline (Day 0) up to Day 28

• Change from Baseline in Parentype Questionnaire

  Baseline (Day 0) up to Day 28

• Weekly Diary Compliance

  Day 1 through Day 28

Study Arms (2)

Baby Wash/Shampoo

EXPERIMENTAL

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

Baby Wash/Shampoo + Baby Lotion

EXPERIMENTAL

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; Other: Baby Lotion

Interventions

Baby Wash/Shampoo OTHER

Parent participant will bathe the baby participant with the baby wash/shampoo at least 3 times per week, but no more than once daily.

Baby Wash/Shampoo; Baby Wash/Shampoo + Baby Lotion

Baby Lotion OTHER

Parent participant will use the baby lotion on baby participants at least once daily.

Baby Wash/Shampoo + Baby Lotion

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

KGL Skin Study Center, LLC

Newtown Square, Pennsylvania, 19073, United States

Location

Related Publications (4)

• 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.

  PMID: 22927835 BACKGROUND

• 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.

  PMID: 22988452 BACKGROUND

• 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.

  PMID: 36204776 BACKGROUND

• Avi Sadeh, D. Sc., Jodi A. Mindell, Ph.D., and Liat Tikotzky, Ph.D. Brief Infant Sleep Questionnaire - Revised Long Form, version January 2020

  BACKGROUND

Study Officials

• Johnson & Johnson Consumer Inc. (J&JCI) Clinical Trial

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 21, 2022
• Study Start: October 25, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)