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Is There an Allergy to Pure Metallic Gold Microparticles?

Primary Purpose

Allergic Reaction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gold microparticles
Gold thiosulphate
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Reaction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic dermatitis

Exclusion Criteria:

  • age < 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Gold microparticles

    Gold thiosulphate

    Arm Description

    Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum

    Gold Sodium Thio Sulphate, 1 % w/v in petrolatum

    Outcomes

    Primary Outcome Measures

    Patch test
    Test materials will be applied on the upper back of the volunteers in aluminium Finn Chambers for 48 hours. Clinical evaluation will be performed 24 hours after removal of the test substances according to standard procedures for evaluation of epicutaneous challenging according to criteria of ICDRG (International Contact Dermatitis Research Group) (Johansen 2015)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2021
    Last Updated
    March 16, 2022
    Sponsor
    Northern Orthopaedic Division, Denmark
    Collaborators
    Aalborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05284253
    Brief Title
    Is There an Allergy to Pure Metallic Gold Microparticles?
    Official Title
    Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northern Orthopaedic Division, Denmark
    Collaborators
    Aalborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators hypothesize gold is inert and thereby there is no pure-gold allergy. The primary aim of this study is to measure the prevalence of allergy to metallic pure gold microparticles and allergy to GSTS.
    Detailed Description
    TRUE test panel which includes gold sodium thiosulphate (GSTS), 1 % w/v in petrolatum, and gold microparticles, 20-micron diameter, 1 % w/v in petrolatum, will be added added to the baseline series. It will be applied to the upper back of healthy adults in aluminum Finn Chamber for 48 hours. Clinical evaluation will be performed 24 hours after removal the test according to standard procedures for evaluation of epi-cutaneous challenging (Johansen 2015).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Reaction

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gold microparticles
    Arm Type
    Experimental
    Arm Description
    Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
    Arm Title
    Gold thiosulphate
    Arm Type
    Active Comparator
    Arm Description
    Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
    Intervention Type
    Other
    Intervention Name(s)
    Gold microparticles
    Other Intervention Name(s)
    Patch test
    Intervention Description
    Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
    Intervention Type
    Other
    Intervention Name(s)
    Gold thiosulphate
    Other Intervention Name(s)
    Patch test
    Intervention Description
    Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
    Primary Outcome Measure Information:
    Title
    Patch test
    Description
    Test materials will be applied on the upper back of the volunteers in aluminium Finn Chambers for 48 hours. Clinical evaluation will be performed 24 hours after removal of the test substances according to standard procedures for evaluation of epicutaneous challenging according to criteria of ICDRG (International Contact Dermatitis Research Group) (Johansen 2015)
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic dermatitis Exclusion Criteria: age < 18
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sten Rasmussen, PhD
    Phone
    25520462
    Email
    sten@dcm.aau.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sten Rasmussen, PhD
    Organizational Affiliation
    Department of Clinical Medicine, Aalborg Unviversity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Is There an Allergy to Pure Metallic Gold Microparticles?

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