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

NCT04740892 | Completed

• 1 other identifier: CCSSKB003103
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, Week 4

• 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).

  Baseline, Week 4

Secondary Outcomes (13)

• Change From Baseline in Skin Microbiome

  Baseline, Day 1, 3, 7 and Week 4

• Change From Baseline in EASI

  Baseline, Day 1, 3 and 7

• Change From Baseline in ADSI

  Baseline, Day 1, 3 and 7

• Change From Baseline in Caregiver Itch Assessment Score

  Baseline, Day 1, 3, 7 and Week 4

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

  Baseline, Day 1, 3, 7 and Week 4

Study Arms (1)

Wash and Cream Investigational Product (IP)

EXPERIMENTAL

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; Other: Cream IP

Interventions

Wash IP OTHER

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.

Wash and Cream Investigational Product (IP)

Cream IP OTHER

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

Wash and Cream Investigational Product (IP)

Eligibility Criteria

• Age: 3 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (2)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24591, United States

Location

Related Publications (7)

• 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.

  PMID: 17903619 BACKGROUND

• 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.

  PMID: 22310478 BACKGROUND

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

  PMID: 2800895 BACKGROUND

• 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.

  PMID: 11168575 BACKGROUND

• 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.

  PMID: 23909890 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zoe Diana Draelos, MD

  Dermatology Consulting Services, PLLC

  PRINCIPAL INVESTIGATOR

• Laura M Brooks, M.D.

  The Education & Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 5, 2021
• Study Start: January 21, 2021
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)