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Dermatitis, AtopicNCT04740892

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

A study testing Wash IP and Cream IP in people with Dermatitis, Atopic, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 72 months
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Wash IP and Cream IP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
21 Jan 2021to 6 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 72 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina, 27262

  • The Education & Research Foundation, Inc.

    Lynchburg, Virginia, 24591

Other trials in United States

About this study

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

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.

Being tested
Wash IP, Cream IP
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wash IPOther

    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.

  • Cream IPOther

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

Study groups in NCT04740892
Study groupRoleWhat they receive
Wash and Cream Investigational Product (IP)ExperimentalParent 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.
Receives: Other: Wash IP; Other: Cream IP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 4

  2. 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).

    Measured: Baseline, Week 4

Secondary outcomes (13)

  1. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  2. Change From Baseline in EASI

    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).

    Measured: Baseline, Day 1, 3 and 7

  3. Change From Baseline in ADSI

    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).

    Measured: Baseline, Day 1, 3 and 7

  4. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  5. 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).

    Measured: Baseline, Day 1, 3, 7 and Week 4

  6. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  7. 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.

    Measured: Baseline (immediately after first use) and Week 4

  8. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  9. 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.

    Measured: Day 1, 3, 7 and Week 4

  10. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  11. 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.

    Measured: Day 1, 3, 7 and Week 4

  12. 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.

    Measured: Baseline, Day 1, 3, 7 and Week 4

  13. 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.

    Measured: Day 1, 3, 7 and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start21 Jan 2021
  3. Primary completion6 Feb 2023
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04740892
Sponsor's protocol ID
CCSSKB003103
Other IDs
CCSSKB003103
Status last verified
Jan 2024
First submitted
21 Jan 2021
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 17903619

  • 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.

    PubMed 22310478

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

    PubMed 2800895

  • 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.

    PubMed 11168575

  • 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.

    PubMed 23909890

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Wash IP and Cream IP in people with Dermatitis, Atopic, run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use (time frame: Baseline, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04740892, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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