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Whole-Body Balm for Healthy Newborn Babies
N/A
Waitlist Available
Led By Todd Bertoch, M.D.
Research Sponsored by Johnson & Johnson Consumer Inc. (J&JCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
Study Summary
This trial studies how safe and effective a special balm is for newborns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
Secondary outcome measures
Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures
Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Whole-body Balm + Wash and ShampooExperimental Treatment2 Interventions
Parent participant will be instructed to apply the whole-body balm on the newborn baby's whole body (excluding the mouth, eyes, diaper area, and scalp) two times per day (morning and evening), and to cleanse the newborn baby with the wash and shampoo at least once per week and no more than three times per week up to Day 28.
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Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,466 Total Patients Enrolled
Todd Bertoch, M.D.Principal InvestigatorCenExel JBR
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have given birth to a full-term infant, either vaginally or via Caesarean section.You are allergic to or have had bad reactions to typical skincare products.Either your parent or sibling has eczema or atopic dermatitis.Only newborns are eligible.Are you male or female?You have reported no major health issues in your medical history.Participants aged between 0-7 days, 8-14 days and 15-28 days old will be recruited in groups of 10 each.You have a skin condition like psoriasis, eczema, or active skin cancer that could affect the study or put your newborn at risk.You have a parent-reported natural skin tone/skin color falling within one of the following categories: Pale/Fair to Light White, White to Light Beige, Beige to Light Tan/Light Olive, Medium Tan/Medium Olive to Light Brown, Medium Brown to Dark Brown or Darkest Brown to Darkest Black
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Whole-body Balm + Wash and Shampoo
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial encompass individuals over the age of 25?
"This research trial has a very specific inclusion criterion, inviting infants aged 0 to 28 days old. Whereas there are 55 trials for minors and 375 studies targeting elderly individuals."
Answered by AI
Is it possible to volunteer for this medical experiment?
"For this trial, 30 infants (age range 0 Days to 28 Days) who are in good health must be recruited. Patients can identify as either male or female and satisfy the additional eligibility requirements."
Answered by AI
Are there any potential participants being welcomed into this clinical trial at present?
"The trial listed on clinicaltrials.gov is no longer accepting participants - the initial posting and most recent update both occurred on March 15th, 2023. However, there are 836 additional trials actively recruiting patients at this time."
Answered by AI
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