Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Primary Purpose
Allergic Contact Eczema
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Adventan® (methylprednisolone aceponate 0,1%)
Sponsored by
About this trial
This is an interventional supportive care trial for Allergic Contact Eczema
Eligibility Criteria
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).
Sites / Locations
- Dermatology Service, Hospital del Mar, Parc de Salut Mar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adventan® (metilprednisolona aceponato 0,1%)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Erythema intensity by colorimetry.
Eczema intensity by planimetric morphology (ICDRG scale)
VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)
Full Information
NCT ID
NCT01529320
First Posted
February 6, 2012
Last Updated
May 11, 2016
Sponsor
Fundacion IMIM
Collaborators
Adknoma Health Research, Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01529320
Brief Title
Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Official Title
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion IMIM
Collaborators
Adknoma Health Research, Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Eczema
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adventan® (metilprednisolona aceponato 0,1%)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adventan® (methylprednisolone aceponate 0,1%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Erythema intensity by colorimetry.
Time Frame
5 days
Title
Eczema intensity by planimetric morphology (ICDRG scale)
Time Frame
5 days
Title
VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Dermatology Service, Hospital del Mar, Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
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Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
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