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

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

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.

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