Is There an Allergy to Pure Metallic Gold Microparticles?

NCT ID: NCT05284253

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-30

Brief Summary

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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

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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).

Conditions

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Allergic Reaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Gold microparticles

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

Group Type EXPERIMENTAL

Gold microparticles

Intervention Type OTHER

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

Gold thiosulphate

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

Group Type ACTIVE_COMPARATOR

Gold thiosulphate

Intervention Type OTHER

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

Interventions

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Gold microparticles

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

Intervention Type OTHER

Gold thiosulphate

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

Intervention Type OTHER

Other Intervention Names

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Patch test Patch test

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic dermatitis

Exclusion Criteria

* age \< 18
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sten Rasmussen, MD, PhD

Professor Head of Department of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sten Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Medicine, Aalborg Unviversity

Central Contacts

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Sten Rasmussen, PhD

Role: CONTACT

Other Identifiers

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NorthernODD

Identifier Type: -

Identifier Source: org_study_id

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