Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

Fundacion IMIM

Status and phase: Completed; Phase 1

Conditions: Allergic Contact Eczema

Treatments: Drug: Adventan® (methylprednisolone aceponate 0,1%)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01529320

2011-005284-25 (EudraCT Number)

GIM-MPA-2011-01

Details and patient eligibility

About

Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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18 participants in 1 patient group

Adventan® (metilprednisolona aceponato 0,1%)

Experimental group

Treatment:

Drug: Adventan® (methylprednisolone aceponate 0,1%)