Is There an Allergy to Pure Metallic Gold Microparticles?
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedJanuary 30, 2024
January 1, 2024
3 months
November 21, 2021
January 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Gold microparticles
EXPERIMENTALMetallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Gold thiosulphate
ACTIVE COMPARATORGold Sodium Thio Sulphate, 1 % w/v in petrolatum
Interventions
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
Eligibility Criteria
You may qualify if:
- Patients with chronic dermatitis
You may not qualify if:
- age \< 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northern Orthopaedic Division, Denmarklead
- Aalborg Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sten Rasmussen, PhD
Department of Clinical Medicine, Aalborg Unviversity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Head of Department of Clinical Medicine
Study Record Dates
First Submitted
November 21, 2021
First Posted
March 17, 2022
Study Start
June 1, 2024
Primary Completion
August 31, 2024
Study Completion
October 30, 2024
Last Updated
January 30, 2024
Record last verified: 2024-01