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

NCT04740892

CompletedNA

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Conditions: Dermatitis, Atopic

Interventions: Wash IP, Cream IP

Countries: United States

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 overview

Sex: ALL

Age: 3 Months to 72 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

High Point, North Carolina, United States
Lynchburg, Virginia, United States