An interventional study of Gold microparticles and Gold thiosulphate in Allergic Reaction, sponsored by Northern Orthopaedic Division, Denmark. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Diagnostic
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.
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).
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Other: Gold microparticles
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
Other: Gold thiosulphate
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Also known as: Patch test
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
Also known as: Patch test
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
Time frame: 72 hours
No study locations are listed for this record.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark