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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT05413395
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
* Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
* Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
* Generally good health based on reported history.
* Able to discontinue all medical and over the counter topical emollients, moisturizers, and / or other skin barrier lotions.
* Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug.
* Ability to administer topical medication and be willing to adhere to the study interventions.
* Agreement to adhere to Lifestyle Considerations throughout the duration of the study.
Exclusion Criteria:
* Pregnancy or lactation.
* Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
* Known allergy to hydrocortisone or topical antibiotic.
* Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
* Bleach bathing in the 7 days prior to Baseline clinical visit.
* Current use of Class I-III topical corticosteroids or systemic medications (e.g. Dupixent) potentially affecting eczema or the skin.
* Surgeries or invasive medical procedures planned during course of study.
* Suspected non-compliance or non-cooperation.
* Intake of experimental drugs or experimental topical skin treatments within 30 days prior to study start.
* Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
* Diagnosis of human immunodeficiency virus in medical history.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05413395
Study Brief:
Protocol Section:
NCT05413395