A Study of a Whole-Body Balm on Newborn Babies

March 11, 2024 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

A Single-Center, Four Week Usage Clinical Study to Evaluate the Tolerance and Efficacy of a Whole-Body Balm on Newborn Babies

The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and perceived product efficacy of a whole-body balm on newborns (0-28 days old).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • CenExcel JBR

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Newborn participants only:

  • Male or Female
  • 0 to 3 months old, targeting at least 15 subjects in the 0 - 28 days age range at time of enrollment.
  • Has Parent Participant-reported Natural Skin tone/skin Color As Follows, including: (a) Skin tones "Pale/fair to light white" and/or "White to light beige" approximately 10 participants; (b) Skin tones "Beige to light tan/light olive" and/or "Medium tan/medium olive to light brown" approximately 10 participants; (c) Skin tones "Medium brown to dark brown" and/or "Darkest brown to darkest black" approximately 10 participants
  • Full term (37 plus weeks of gestation, both vaginal and Caesarean mode of delivery can be included) newborn

Newborn participant and parent participant:

  • Generally, in good health based on medical history reported by the parent participant

Parent participant only:

  • Able to read, write, speak, and understand English
  • At least 18 years old and is the parent (adoptive or biological), legal guardian, and primary caregiver of the newborn participant
  • Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
  • Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

Newborn participant only:

  • Presents with a skin condition that may influence the outcome of the study or increase risk to the newborn participant (example , psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
  • Has a family history of (defined as having a biological parent or full sibling with) eczema/atopic dermatitis
  • Has been bathed within 3 hours prior to Visit 1
  • Has a clinical grade greater than 0 for rash/irritation, or greater than or equal to 1 for any of the other clinically assessed tolerance parameters at Visit 1

Newborn participant and parent participant:

  • Has known allergies or adverse reactions to common topical skincare products
  • Has self-reported (for the parent participant) or parent participant reported (for the newborn participant) Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
  • Is taking a medication that would mask an AE or confound the study results, including (a) Immunosuppressive or steroidal drugs within 3 months before Visit 1; (b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; (C) Antihistamines within 2 weeks (14 days) before Visit 1

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whole-body Balm + Wash and Shampoo
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.
Other: Whole-body Balm
Balm will be applied to cover newborn's entire body (while avoiding the mouth, eyes, diaper area, and scalp), and gently massaged onto the skin until the balm is fully absorbed.
Other: Wash and Shampoo
Wash and shampoo will be used to cleanse newborn baby using an "in tub" bathing method.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
Time Frame: Change from baseline after 4 weeks
Change from baseline after 4 weeks of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.
Change from baseline after 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures
Time Frame: Change from baseline after 7 days
Change from baseline after 7 days of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.
Change from baseline after 7 days
Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
Time Frame: Change from baseline after 7 days
Change from baseline after 7 days of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface.
Change from baseline after 7 days
Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
Time Frame: Change from baseline after 4 weeks
Change from baseline after 4 weeks of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface.
Change from baseline after 4 weeks
Number of Response Options for Each Question in the Parental Questionnaire
Time Frame: Day 28
Number of response options for each question in the parental questionnaire will be reported. Parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'.
Day 28
Percentage of All Response Options for Each Question in the Parental Questionnaire
Time Frame: Day 28
Percentage of all response options for each question in the parental questionnaire will be reported. parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'.
Day 28

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd Bertoch, M.D., Cenexel JBR

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

  • https://www.courage-khazaka.de/en/scientific-products/all-products/16-wissenschaftliche-produkte/alle-produkte/183-corneometer-e.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCSSKB005124 (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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