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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT02680405
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained prior to any study related procedure taking place.
2. Male or Female age 18-65 years inclusive at the time of screening
3. Current disease state meeting the Hanifin and Rajka criteria for AD Or Non-atopic with no history of skin disease
4. Atopic dermatitis that affects ≥ 15% body surface area (BSA)
5. No clinically significant abnormality on the basis of medical/medication history or physical examination
Exclusion Criteria:
Subjects who meet any of the following criteria will not be eligible:
1. Active dermatologic conditions which may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis or psoriasis
2. Known active allergic or irritant contact dermatitis
3. Use of topical corticosteroids or humectants (e.g. containing urea or lactic acid) within 7 days of Visit 1 and throughout the study. Standard occlusives and emollients are permitted
4. Treatment of AD with a medical device (e.g. Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 7 days of Visit 1 and throughout the study. Standard occlusive and emollients are permitted.
5. Use of tanning beds or phototherapy within 8 weeks
6. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit, whichever is longer
7. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to Visit, whichever is longer
8. Treatment with the following medications within the last 4 weeks prior to Visit:
* systemic immunosuppressive/immunomodulating drugs ((eg, methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon gamma, intramuscular long-acting depot corticosteroid).)
* Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery)
* Topical calcineurin inhibitor use
9. Known history of allergy or reaction to tape or adhesives
10. Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02680405
Study Brief:
Protocol Section:
NCT02680405