Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

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

Official Title
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Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).

Conditions
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Allergic Contact Eczema

Intervention / Treatment
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* Drug: Adventan® (methylprednisolone aceponate 0,1%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years old. Subjects with a history of diagnosis of sensitization to Nickel sulphate. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test. Skin Phototype II-III. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study. Written informed consent prior to inclusion. 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: Active cutaneous disease causing itch (active eczema, urticaria or insect bites) Active systemic disease that may induce itch (hepatic or renal disease). Active psychiatric disease that could interfere with symptom assessment. Treatment with drugs inducing itch. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen Pregnancy or lactation Subjects with contraindications specified in Summary of Product Characteristics (SPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adventan® (metilprednisolona aceponato 0,1%)<br> | Drug: Adventan® (methylprednisolone aceponate 0,1%)<br>* Doses: 1/4 FTU (Finger Tip Unit) during 5 days (Day 7-Day 11). Procedure: Patch Test (Nickel sulphate 5%) during 2 days (Day 0- Day 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate. | Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema intensity by colorimetry. |  | 5 days | 
| Eczema intensity by planimetric morphology (ICDRG scale) |  | 5 days | 
| VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT) |  | 5 days |