Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||3 Months - 72 Months|
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.
- - Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Johnson & Johnson Consumer Inc. (J&JCI)|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Laura M Brooks, MD|
|Principal Investigator Affiliation||The Education & Research Foundation, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Wash and Cream Investigational Product (IP)
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
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.
Other: - Cream IP
Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.