Status:
COMPLETED
A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
3-72 years
Phase:
NA
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04740892
Start Date
January 21 2021
End Date
February 6 2023
Last Update
February 6 2024
Active Locations (2)
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1
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States, 27262
2
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24591