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Baby Wash/Shampoo + Baby Lotion for Healthy Subjects

N/A
Waitlist Available
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
For Baby only: Fitzpatrick Skin Types I - VI
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 28
Awards & highlights

Study Summary

This trial tests how a baby wash/shampoo and lotion combo affects newborns' skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The study is open to babies of all skin types, from very fair to very dark.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 for reporting.

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 in Clinical Assessment of Cutaneous Tolerance scores
Change from Baseline in Parental Assessment Score
Secondary outcome measures
Change from Baseline in Metabolome
Change from Baseline in Microbiome
Change from Baseline in Parentype Questionnaire
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Baby Wash/Shampoo + Baby LotionExperimental Treatment2 Interventions
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.
Group II: Baby Wash/ShampooExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,441 Total Patients Enrolled
Johnson & Johnson Consumer Inc. (J&JCI) Clinical TrialStudy DirectorJohnson & Johnson Consumer Inc. (J&JCI)
2 Previous Clinical Trials
144 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the desirable outcomes of this scientific evaluation?

"According to the information reported by J&JCI, which is the study sponsor, Change from Baseline in Parental Assessment Score will be measured over a period of 28 days and serve as the primary outcome. Additionally, secondary outcomes such as changes in skin pH levels, metabolome samples and product questionnaires completed by parent participants will also be assessed."

Answered by AI

Is the age eligibility for this trial restricted to individuals under 25 years old?

"The eligibility requirements stipulate that those looking to participate in this trial must be infants between the ages of 0 and 28 days old. The primary cohort is made up of 50 minors, while 371 adults over 65 are also being surveyed."

Answered by AI

Are there any participant vacancies for this experiment?

"Affirmative. Evidenced on clinicaltrials.gov, this experiment is currently recruiting patients and was initially launched during October 25th 2022. The most recent update to this trial's information occurred on November 28th of the same year. 60 individuals are needed across a solitary medical facility for successful completion of the study."

Answered by AI

How many participants are enrolled in this clinical experiment?

"Indeed, according to the information on clinicaltrials.gov this experimental trial is presently open for recruitment. It was initiated on October 25th 2022 and modified lastly on November 28th 2022, with an estimated quota of 60 participants across 1 study site."

Answered by AI

Could I be a candidate for this medical trial?

"This research project is seeking 60 participants ranging from newly-borns to 28 day old infants. Essential requirements include: satisfactory health records and well being of the baby, Fitzpatrick Skin Types I - VI, parental legal guardianship with relevant documents to prove it, ability to read/write English language fluently and comprehend instructions given in the Informed Consent Document (ICD) including HIPAA disclosure form , uninterrupted access to internet for completing questionnaires & surveys as part of study protocols, willingness and capacity for adhering fully till completion of trial period."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
KGL Skin Study Center, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby Apr 2025