Is There an Allergy to Pure Metallic Gold Microparticles?

January 26, 2024 updated by: Sten Rasmussen, MD, PhD, Northern Orthopaedic Division, Denmark

Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with chronic dermatitis

Exclusion Criteria:

  • age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gold microparticles
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Other: Gold microparticles
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Other Names:
  • Patch test
Active Comparator: Gold thiosulphate
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
Other: Gold thiosulphate
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
Other Names:
  • Patch test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patch test
Time Frame: 72 hours
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). Reactions: doubtfull, faint macular erythema only; weak positive reaction, erythema, infiltration papules; strong positive reaction, erythema, infiltration, papular, vesicles; erythema positive reaction, intense erythema, infiltration and coalescing vesicles; negative reaction; irritant reaction; not tested
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Aalborg University

Investigators

  • Principal Investigator: Sten Rasmussen, PhD, Department of Clinical Medicine, Aalborg Unviversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthernODD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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