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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT03461302
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AD based on the criteria of Hanifin and Rajka
* Moderate to severe AD based on EASI score \>7.1
* Willing and able to comply with visits and study-related procedures
* Provide signed informed consent (if patient \>12 years of age) and/or signed informed consent provided by the parents or legal guardian (all participating patients)
* Able to understand and complete study-related questionnaires, or parent or legal guardian is able to understand and complete study-related questionnaires
* Willing to avoid excessive sunlight
Exclusion Criteria:
* Hypersensitivity and/or intolerance to topical corticosteroids or topical coal tar
* Treatment with any of the following before baseline:
* Topical treatment with corticosteroids within 24 hours before baseline
* Topical treatment with coal tar, tacrolimus and/or pimecrolimus within 2 weeks before baseline
* Topical treatment with antibiotics or antifungal treatment within 7 days before baseline
* Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy for AD within 8 weeks before baseline
* Investigational drugs within 8 weeks or 5 half-lives (whichever is longer)
* Use of systemic antibiotic therapy, systemic antifungal therapy and/or biologicals within 6 months before baseline
* Planned or anticipated use of any prohibited medication during the treatment and follow-up period:
* Other medication than the prescribed study medication used for the treatment of AD, including topical calcineurin inhibitors, prescription moisturizers containing additives such as urea, antihistamines, phototherapy, systemic treatment with an immunosuppressive/immunomodulatory agent such as cyclosporine, methotrexate or biologics
* Systemic antibiotic and/or antifungal therapy
* Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than moderate potency topical corticosteroids
* Pregnancy or breast feeding, or planning to become pregnant or breast feed
* Presence of skin co-morbidities that may interfere with study assessments
* Presence of concomitant illness that would, in the investigator's judgment, adversely affect the patient's participation in the study
* Presence of chronic hepatic or renal insufficiency
* Presence of immunodeficiency syndromes including HIV
* Presence of HBV or HCV
* Any other medical or psychological condition that would represent an unreasonable risk to the patient, make the patient's participation unreliable or interfere with study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT03461302
Study Brief:
Protocol Section:
NCT03461302