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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wash IP

Cream IP

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

3 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dermatology Consulting Services, PLLC
The Education & Research Foundation, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wash and Cream Investigational Product (IP)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use

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).

Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use

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).

Secondary Outcome Measures

Change From Baseline in Skin Microbiome

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.

Change From Baseline in EASI

Change From Baseline in ADSI

Change From Baseline in Caregiver Itch Assessment Score

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.

Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL)

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).

Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score

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.

Parent Perceived Product Efficacy as Assessed by Parental Questionnaire

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.

Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site

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.

TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site

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.

Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site

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.

Skin Hydration Difference between Lesion and Adjacent Non-lesional Site

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.

Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site

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.

Skin pH Difference between Lesion and Adjacent Non-lesional Site

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.

Full Information

NCT ID

NCT04740892

First Posted

January 21, 2021

Last Updated

March 20, 2023

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

1. Study Identification

Unique Protocol Identification Number

NCT04740892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

February 6, 2023 (Actual)

Study Completion Date

February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wash and Cream Investigational Product (IP)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Wash IP

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Cream IP

Intervention Description

Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use

Description

Time Frame

Baseline, Week 4

Title

Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use

Description

Time Frame

Baseline, Week 4

Secondary Outcome Measure Information:

Title

Change From Baseline in Skin Microbiome

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Change From Baseline in EASI

Description

Time Frame

Baseline, Day 1, 3 and 7

Title

Change From Baseline in ADSI

Description

Time Frame

Baseline, Day 1, 3 and 7

Title

Change From Baseline in Caregiver Itch Assessment Score

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL)

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Parent Perceived Product Efficacy as Assessed by Parental Questionnaire

Description

Time Frame

Baseline (immediately after first use) and Week 4

Title

Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site

Description

Time Frame

Day 1, 3, 7 and Week 4

Title

Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Skin Hydration Difference between Lesion and Adjacent Non-lesional Site

Description

Time Frame

Day 1, 3, 7 and Week 4

Title

Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site

Description

Time Frame

Baseline, Day 1, 3, 7 and Week 4

Title

Skin pH Difference between Lesion and Adjacent Non-lesional Site

Description

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.

Time Frame

Day 1, 3, 7 and Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

72 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zoe Diana Draelos, MD

Organizational Affiliation

Dermatology Consulting Services, PLLC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura M Brooks, M.D.

Organizational Affiliation

The Education & Research Foundation, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Consulting Services, PLLC

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

The Education & Research Foundation, Inc.

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24591

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

http://yoda.yale.edu

Citations:

PubMed Identifier

17903619

Citation

Lipozencic J, Wolf R. Atopic dermatitis: an update and review of the literature. Dermatol Clin. 2007 Oct;25(4):605-12, x. doi: 10.1016/j.det.2007.06.009.

Results Reference

background

PubMed Identifier

22310478

Citation

Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.

Results Reference

background

PubMed Identifier

2800895

Citation

Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.

Results Reference

background

PubMed Identifier

11168575

Citation

Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.

Results Reference

background

PubMed Identifier

23909890

Citation

Basra MK, Gada V, Ungaro S, Finlay AY, Salek SM. Infants' Dermatitis Quality of Life Index: a decade of experience of validation and clinical application. Br J Dermatol. 2013 Oct;169(4):760-8. doi: 10.1111/bjd.12563.

Results Reference

background

Citation

National Psoriasis Foundation, "Topical Steriods Potency Chart," 18 December 2020, [Online]. Available: http;//www.psoriasis.org/potency_chart/.

Results Reference

background

Citation

Avi Sadeh, D. Sc., Jodi A. Mindell, Ph.D., and Liat Tikotzky, Ph.D. Brief Infant Sleep Questionnaire - Revised Long Form, version January 2020

Results Reference

background

Learn more about this trial

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

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