A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

February 2, 2024 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

A Clinical Evaluation of the Safety and Efficacy of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception) of the investigational cream when used in conjunction with a baby wash in babies, toddlers, and children with mild to moderate atopic dermatitis.

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.
31

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
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC
    • Virginia
      • Lynchburg, Virginia, United States, 24591
        • The Education & Research Foundation, Inc.

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

3 months to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Child

  • Fitzpatrick skin type I to VI
  • Child must have at least 1 target lesion based on the atopic dermatitis severity index (ADSI) with a score of 2-12 and an erythema sub score of at least 2 (moderate)
  • Has mild to moderate atopic dermatitis (as per Rajka-Langeland Severity Index; graded as 3.0 to 7.5 inclusive)
  • Child must have parent-assessed history of itch
  • Has parent-perceived sensitive skin For Parents
  • Willing to undergo a 3-day washout period prior to the baseline assessments. During this run-in period, parents will be asked to refrain from using prescription and over-the-counter (OTC) eczema treatments on their child; Acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator [PI])
  • Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure

Exclusion Criteria:

  • Has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (IPs)
  • Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to Visit 1 For Child
  • Presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer)
  • Severe atopic dermatitis (AD) as determined by the Rajka-Langeland Severity Index For Parent
  • Is self-reported to be pregnant or planning to become pregnant during the study

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: Treatment
  • 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: Wash and Cream Investigational Product (IP)
Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks. Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
Other: Wash IP
Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks.
Other: Cream IP
Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.

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 in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use
Time Frame: Baseline, Week 4
EASI is a composite scoring system index which is used to measure the severity of 4 clinical manifestations of atopic dermatitis (erythema, edema/induration/papulation, excoriations, and lichenification) according to the percentage of affected area in each of the 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Final scores range from 0 (no disease anywhere on the body) to 72 (severest disease on all body areas).
Baseline, Week 4
Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use
Time Frame: Baseline, Week 4
ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Baseline, Week 4

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 in Skin Microbiome
Time Frame: Baseline, Day 1, 3, 7 and Week 4
Change from baseline in skin microbiome in lesion versus adjacent non-lesional site will be assessed. Microbiome samples collected from the identified lesional site and an adjacent non-lesional site by swabbing technique will be analyzed by using 16s ribonucleic acid (RNA) sequencing.
Baseline, Day 1, 3, 7 and Week 4
Change From Baseline in EASI
Time Frame: Baseline, Day 1, 3 and 7
EASI is a composite scoring system index which is used to measure the severity of 4 clinical manifestations of atopic dermatitis (erythema, edema/induration/papulation, excoriations, and lichenification) according to the percentage of affected area in each of the 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Final scores range from 0 (no disease anywhere on the body) to 72 (severest disease on all body areas).
Baseline, Day 1, 3 and 7
Change From Baseline in ADSI
Time Frame: Baseline, Day 1, 3 and 7
ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Baseline, Day 1, 3 and 7
Change From Baseline in Caregiver Itch Assessment Score
Time Frame: Baseline, Day 1, 3, 7 and Week 4
Parent participant will assess how much itching/scratching the child participant has been exhibiting on a scale of 1 (none) to 4 (all the time). An option of "I don't have an opinion" will be included.
Baseline, Day 1, 3, 7 and Week 4
Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL)
Time Frame: Baseline, Day 1, 3, 7 and Week 4
IDQoL is a validated questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life in infants aged 0-3 years. The Infant's Dermatitis Quality of Life Index is calculated by summing the score of each question: for question 1 (0 [none] to 3 [all the time]), For question 2 (0 [happy] to 3 [always crying]), For question 3 (0 [0-15 minutes to 3 [More than 2 hours]), For question 4 (0 [less than one hour] to 3 [Five hours or more]), and For questions 5 to 10 (0 [None] to 3 [Very much]), resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The severity of eczema is scored separately and can be correlated with the Infants' Dermatitis Quality of Life Index. The score of Dermatitis severity ranges from 0 (None) to 4 (Extremely severe).
Baseline, Day 1, 3, 7 and Week 4
Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score
Time Frame: Baseline, Day 1, 3, 7 and Week 4
BISQ-R is an age-based, norm-referenced scoring system that provides a comprehensive assessment of infant and toddler sleep patterns. Five (5) items related to sleep onset latency, number, and duration of night wakings, longest stretch of sleep and total night sleep. Parent perception consists of 3 items related to bedtime difficulty, overnight sleep, and overall child sleep problems. Parent behaviors consisting of 11 items related to bedtime routine consistency, bedtime, parental behavior at time of sleep onset and night wakings, sleep locations at time of sleep onset and following night wakings that may impact sleep outcomes. Score ranging from 0-100 is derived for each sub-scale, with higher scores denoting better sleep quality, more positive perceptions of sleep quality, and parental habits that promote healthy sleep behaviors and independent infant sleep, respectively. Total score is calculated as an average of infant sleep, parent perceptions and parent behavior subscale scores.
Baseline, Day 1, 3, 7 and Week 4
Parent Perceived Product Efficacy as Assessed by Parental Questionnaire
Time Frame: Baseline (immediately after first use) and Week 4
Parent perceived product efficacy will be assessed by using parental questionnaire. Participant responses for each question will have 5 response options, the following numerical assignment could be one of the following choices: (1) Strongly Disagree, (2) Disagree Somewhat, (3) Neither Disagree or Agree, (4) Agree Somewhat, (5) Strongly Agree.
Baseline (immediately after first use) and Week 4
Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site
Time Frame: Baseline, Day 1, 3, 7 and Week 4
Change from Baseline in TEWL measurement on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab TEWL instrument uses a non-invasive probe, which measures the passive transfer of water through the stratum corneum.
Baseline, Day 1, 3, 7 and Week 4
TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site
Time Frame: Day 1, 3, 7 and Week 4
TEWL measurement difference between lesional site and an adjacent non-lesional site will be reported. The DermaLab TEWL instrument uses a non-invasive probe, which measures the passive transfer of water through the stratum corneum.
Day 1, 3, 7 and Week 4
Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site
Time Frame: Baseline, Day 1, 3, 7 and Week 4
Change from Baseline in skin hydration on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab hydration instrument uses a non-invasive probe, which measures the water content of the stratum corneum.
Baseline, Day 1, 3, 7 and Week 4
Skin Hydration Difference between Lesion and Adjacent Non-lesional Site
Time Frame: Day 1, 3, 7 and Week 4
Skin hydration difference between lesion and adjacent non-lesional site will be reported. The DermaLab hydration instrument uses a non-invasive probe, which measures the water content of the stratum corneum.
Day 1, 3, 7 and Week 4
Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site
Time Frame: Baseline, Day 1, 3, 7 and Week 4
Change from Baseline in skin pH on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab skin pH instrument uses a non-invasive probe, which measures the pH of the stratum corneum.
Baseline, Day 1, 3, 7 and Week 4
Skin pH Difference between Lesion and Adjacent Non-lesional Site
Time Frame: Day 1, 3, 7 and Week 4
Skin pH difference between lesion and adjacent non-lesional site will be reported. The DermaLab skin pH instrument uses a non-invasive probe, which measures the pH of the stratum corneum.
Day 1, 3, 7 and Week 4

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: Zoe Diana Draelos, MD, Dermatology Consulting Services, PLLC
  • Principal Investigator: Laura M Brooks, M.D., The Education & Research Foundation, Inc.

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

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.
January 21, 2021

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.
February 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.
February 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).
January 21, 2021

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.
February 4, 2021

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.
February 5, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
February 6, 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.
February 2, 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.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CCSSKB003103 (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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