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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Other: Wash IP; Other: Cream IP

Study type: Interventional

Funder types: Industry

Identifiers

NCT04740892

CCSSKB003103 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 3 to 72 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Wash and Cream Investigational Product (IP)

Experimental group

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.

Treatment:

Other: Cream IP

Other: Wash IP