Clinical trial NCT04740892: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use
timeFrame: Baseline, Week 4
measure: Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Skin Microbiome
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Change From Baseline in EASI
timeFrame: Baseline, Day 1, 3 and 7
measure: Change From Baseline in ADSI
timeFrame: Baseline, Day 1, 3 and 7
measure: Change From Baseline in Caregiver Itch Assessment Score
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL)
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Parent Perceived Product Efficacy as Assessed by Parental Questionnaire
timeFrame: Baseline (immediately after first use) and Week 4
measure: Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site
timeFrame: Day 1, 3, 7 and Week 4
measure: Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Skin Hydration Difference between Lesion and Adjacent Non-lesional Site
timeFrame: Day 1, 3, 7 and Week 4
measure: Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site
timeFrame: Baseline, Day 1, 3, 7 and Week 4
measure: Skin pH Difference between Lesion and Adjacent Non-lesional Site
timeFrame: Day 1, 3, 7 and Week 4
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Dermatology Consulting Services, PLLC
name: Zoe Diana Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Education & Research Foundation, Inc.
name: Laura M Brooks, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: National Psoriasis Foundation, "Topical Steriods Potency Chart," 18 December 2020, [Online]. Available: http;//www.psoriasis.org/potency_chart/.
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