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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT03059693
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe atopic dermatitis as determined by Physician's Global Assessment (PGA \> 3)
* Males and females, age 12 - 65 years old inclusive
Exclusion Criteria:
* Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
* Currently or has been diagnosed or treated for cancer in the past 5 years.
* Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
* Has a known hypersensitivity to any corticosteroid creams.
* Has any active infections or has used antibiotics in the past 7 days.
* Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne)
* Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
* Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
* Is an employee of the sponsor company or clinical testing site.
* Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
* Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
* Has a history of keloid formation following skin injury.
* Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin, heparin, etc.)
* Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT03059693
Study Brief:
Protocol Section:
NCT03059693