Back to results

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%)

About this trial

This is an interventional supportive care trial for Allergic Contact Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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 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

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

Learn more about this trial

Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

We'll reach out to this number within 24 hrs