Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Contact Eczema
• Intervention / Treatment: Drug: Adventan® (methylprednisolone aceponate 0,1%)

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Dermatology Service, Hospital del Mar, Parc de Salut Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adventan® (metilprednisolona aceponato 0,1%)	Drug: Adventan® (methylprednisolone aceponate 0,1%); 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Fundacion IMIM
• Collaborators: Bayer; Adknoma Health Research

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Contact; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Methylprednisolone aceponate
• Other Study ID Numbers: GIM-MPA-2011-01; 2011-005284-25 (EudraCT Number)