Is There an Allergy to Pure Metallic Gold Microparticles?

Northern Orthopaedic Division, Denmark

Status: Not yet enrolling

Conditions: Allergic Reaction

Treatments: Other: Gold microparticles; Other: Gold thiosulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT05284253

NorthernODD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic dermatitis

Exclusion criteria

• age < 18

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Gold microparticles

Experimental group

Description:

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

Treatment:

Other: Gold microparticles

Gold thiosulphate

Active Comparator group

Description:

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

Treatment:

Other: Gold thiosulphate