A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns
- Conditions
- Healthy
- Interventions
- Other: Baby Wash/ShampooOther: Baby Lotion
- Registration Number
- NCT05589038
- Lead Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 53
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baby Wash/Shampoo + Baby Lotion 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. Baby Wash/Shampoo + Baby Lotion 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, and apply lotion at least once daily after bathing, for 4 weeks. Baby Wash/Shampoo 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Parental Assessment Score 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 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.
- Secondary Outcome Measures
Name Time Method Product Questionnaire as Assessed by Parent Participants 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".
Change from Baseline in Microbiome Baseline (Day 0) up to Day 28 Change in microbiome samples as analyzed in laboratory will be reported.
Change from Baseline in Skin pH Baseline (Day 0) up to Day 28 Change from baseline in skin pH will be reported.
Change from Baseline in Parentype Questionnaire 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.
Change from Baseline in Metabolome Baseline (Day 0) up to Day 28 Change in metabolome samples as analyzed in laboratory will be reported.
Weekly Diary Compliance 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.
Trial Locations
- Locations (1)
KGL Skin Study Center, LLC
🇺🇸Newtown Square, Pennsylvania, United States