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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01950494
Eligibility Criteria:
Inclusion Criteria:
1. Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications.
2. Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5)
3. Physician global assessment (PGA) of moderate to severe (with PGA severity scores graded as in Table 1 of reference 8: severe, moderate, mild, almost clear, clear).
Exclusion Criteria:
1. Topical corticosteroid or calcineurin inhibitor treatment during the last 7 days, prior to enrollment, on the hands and forearms
2. Systemic treatment with corticosteroids or other immunosuppressives during the last 14 days.
3. Subjects currently receiving (or received during the previous 4 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
4. Treatment with ultraviolet (UV) light (including tanning) during the previous 4 weeks.
5. Acute dermatitis outbreak on the arms or hands.
6. Subjects unable to comply with protocol restrictions
7. Subjects known to be unreliable or non-compliant with medical treatment, or unwilling to comply with multiple return visits.
8. Any condition or prior/present treatment, in the opinion of the investigators, should render the patient ineligible for the study
9. Known allergy to benzalkonium chloride or other ingredients in the fiteBac vehicle
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01950494
Study Brief:
Protocol Section:
NCT01950494