Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02120833
Eligibility Criteria:
Inclusion Criteria
1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
2. Caregiver is able and willing to provide written informed consent for the participant to participate in the trial;
3. Male or female of any race or ethnicity, 2 months to 35 months of age;
4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka
5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index
6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period. If using corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be on a stable dose for a minimum of 1 month;
7. Willing to undergo a washout period of 2 days before the trial initiation where no use of moisturizers or emollients will be allowed; and
8. Willing and able to comply with scheduled visits, treatment plan, and other trial procedures.
Exclusion Criteria:
1. Known sensitivity to any investigational product ingredient;
2. Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema;
3. Participation in any clinical study within 30 days of Visit 1;
4. Relative, partner or staff of any clinical research site personnel;
5. Active infection of any type at the start of the study;
6. Severe AD as determined by the Rajka-Langeland Severity Index
7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial;
8. Requires any inhaled or intranasal corticosteroids;
9. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
35 Months
Study:
NCT02120833
Study Brief:
Protocol Section:
NCT02120833