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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT02664805
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid
* Physician's Global Assessment of disease severity graded as at least mild at Visit 1
* In overall good health including well controlled diseases
Exclusion Criteria:
* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
* PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization
* Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization
* Concurrent skin diseases on the hands
* Current diagnosis of exfoliative dermatitis
* Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment
* A marked abnormal ECG at baseline
* Known hepatic dysfunction or hepatic dysfunction tested at Screening
* Current participation in any other interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02664805
Study Brief:
Protocol Section:
NCT02664805