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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01529320
Eligibility Criteria:
Inclusion Criteria:
1. Subjects ≥18 years old.
2. Subjects with a history of diagnosis of sensitization to Nickel sulphate.
3. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
4. Skin Phototype II-III.
5. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
6. Written informed consent prior to inclusion.
7. Able and willing to comply with protocol procedures and to follow the investigator's instructions.
Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.
Exclusion Criteria:
1. Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
2. Active systemic disease that may induce itch (hepatic or renal disease).
3. Active psychiatric disease that could interfere with symptom assessment.
4. Treatment with drugs inducing itch.
5. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
6. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
7. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
8. Pregnancy or lactation
9. Subjects with contraindications specified in Summary of Product Characteristics (SPC).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01529320
Study Brief:
Protocol Section:
NCT01529320