Allergic ReactionNCT05284253
Is There an Allergy to Pure Metallic Gold Microparticles?
A study testing Gold microparticles and Gold thiosulphate in people with Allergic Reaction, run by Northern Orthopaedic Division, Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Reaction
- What is being tested?
- Gold microparticles and Gold thiosulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic dermatitis
Who cannot join
- age < 18
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.
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.
Read the detailed 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).
- Conditions
- Allergic Reaction
- Being tested
- Gold microparticles, Gold thiosulphate
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold microparticlesOther
Also called Patch test
Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum
Gold thiosulphateOther
Also called Patch test
Gold Sodium Thio Sulphate, 1 % w/v in petrolatum
| Study group | Role | What they receive |
|---|---|---|
| Gold microparticles | Experimental | Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum Receives: Other: Gold microparticles |
| Gold thiosulphate | Active comparator | Gold Sodium Thio Sulphate, 1 % w/v in petrolatum Receives: Other: Gold thiosulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Sten Rasmussen, MD, PhD, Aalborg University
- Investigators
- Sten Rasmussen, PhD, Principal investigator, Department of Clinical Medicine, Aalborg Unviversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284253
- Sponsor's protocol ID
- NorthernODD
- Status last verified
- Jan 2024
- First submitted
- 21 Nov 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.
- ClinicalTrials.gov ID
- NCT05284253
- Acronym / sponsor ID
- NorthernODD
- Conditions
- Allergic Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold microparticles | Experimental | Other: Gold microparticlesMetallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum |
| Gold thiosulphate | Active comparator | Other: Gold thiosulphateGold Sodium Thio Sulphate, 1 % w/v in petrolatum |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic dermatitis
Key exclusion criteria (1 listed)
- age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold microparticlesAlso: Patch testMetallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum | Other | Gold microparticles |
| Gold thiosulphateAlso: Patch testGold Sodium Thio Sulphate, 1 % w/v in petrolatum | Other | Gold thiosulphate |
Primary outcome
Patch test
Time frame: 72 hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, PhD principal investigator
Department of Clinical Medicine, Aalborg Unviversity
Questions about this trial
What is this clinical trial studying?
A study testing Gold microparticles and Gold thiosulphate in people with Allergic Reaction, run by Northern Orthopaedic Division, Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sten Rasmussen, PhD (25520462, sten@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patch test (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.