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NCT05284253 Clinical Trial

Is There an Allergy to Pure Metallic Gold Microparticles?

Allergic Reaction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05284253
Other study ID # NorthernODD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date October 30, 2024

Study information
Verified date January 2024
Source Northern Orthopaedic Division, Denmark
Contact Sten Rasmussen, PhD
Phone 25520462
Email sten@dcm.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date October 30, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with chronic dermatitis Exclusion Criteria: - age < 18

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Gold microparticles
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
• Gold thiosulphate
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark Aalborg University

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 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
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