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:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03673059
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate eczema, as determined by the investigator (score of 2.0-7.5 on Rajka-Langeland severity index).
* Has 1 target lesion, as determined by the investigator (score of 6-12 on Atopic Dermatitis Severity Index (ADSI) and sub-score of at least 2 on erythema and pruritus).
* Experienced a recent itch flare up and is experiencing pre-flare up symptoms at screening.
* Did not use moisturizer on the face and body for 3 days prior to screening.
* Has a score of at least 4.0 on Visual Analog Scale (VAS) Itch Assessment scale at baseline.
* Generally in good health.
* Willing to stop using all topical emollients, moisturizers, and/or other skin barrier creams and/or emulsion treatments for the eczema condition during the test period.
* Willing and able to follow all study directions, including avoiding excessive sun exposure (including tanning beds), and to commit to all follow up visits for the duration of the study.
* Completed informed consent/assent process and signed photograph release.
* Must agree to practice a medically acceptable form of birth control.
Exclusion Criteria:
* Known allergies or sensitivities to test product ingredients.
* Severe eczema.
* Using a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
* Has a health condition or skin condition that the study investigator thinks could increase risk to the subject or confuse study results (e.g. immune deficiency disorders).
* Has been using that the study investigator thinks could increase risk to the subject or confuse study results (e.g. corticosteroids, immunosuppressive medications).
* Currently participating in another study.
* Subjects who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
* Has any planned surgery and/or invasive medical procedures scheduled during the course of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT03673059
Study Brief:
Protocol Section:
NCT03673059