A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children
NCT ID: NCT04740892
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2021-01-21
2023-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Cream IP
Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
Interventions
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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.
Cream IP
Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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
3 Months
72 Months
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Zoe Diana Draelos, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Consulting Services, PLLC
Laura M Brooks, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Education & Research Foundation, Inc.
Locations
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Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Countries
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References
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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.
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.
Rajka G, Langeland T. Grading of the severity of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1989;144:13-4. doi: 10.2340/000155551441314.
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.
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.
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
Related Links
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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
Other Identifiers
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CCSSKB003103
Identifier Type: OTHER
Identifier Source: secondary_id
CCSSKB003103
Identifier Type: -
Identifier Source: org_study_id
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