Contact AllergyNCT06042309
Contact Allergy to Rubber Accelerators - a Clinical Study
A study testing SLS and Patch test on back in people with Contact Allergy, run by National Allergy Research Center, Denmark at 2 sites in Denmark.
Trial summary
This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Allergy
- What is being tested?
- SLS and Patch test on back
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Feb 2024to 20 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old
- Sensitized to thiurams, carbamates or both.
- Received written and oral information about the study.
- Signed written consent form
- adults ≥18 years old
- Received written and oral information about the study.
- Signed written consent form
Who cannot join
- Dermatitis on back or arms
- Tattoos or significant scar tissue on exposure areas
- Pregnancy
- Breast feeding
- Recently given birth
- Treatment with systemic immunomodulators within the last 4 weeks
Show all 20Show fewer
- Treatment with local immunomodulators on arms or back within the last 4 weeks
- Excessive ultraviolet light on arms or back within the last 4 weeks
- Healthy Controls:
- Sensitized to thiurams, carbamates or both.
- Occupational or domestical use of rubber gloves.
- History of atopic dermatitis or contact dermatitis
- Dermatitis on back or arms
- Tattoos or significant scar tissue on exposure areas
- Pregnancy
- Breast feeding
- Recently given birth
- Treatment with systemic immunomodulators within the last 4 weeks
- Treatment with local immunomodulators on arms or back within the last 4 weeks
- Excessive ultraviolet light on arms or back within the last 4 weeks
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Dermatology, Gentofte Hospital, Videncenter For Allergi
Hellerup, 2900
Department of Dermatology and Allergy, Odense University Hospital (OUH)
Odense, 5000
About this study
Official title: Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Further, it will investigate whether a damaged skin barrier as caused by wet work increase the severity of the allergic contact dermatitis.
The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.
Read more
Following this, the participants' volar forearms will be exposed to thiurams or carbamates and a control solution every night for 7 nights to simulate the repeated exposure to rubber gloves with accelerators. The skin reactions will be read cf. current international guidelines and further quantified using laser Doppler flowmetry.
During the study, all participants will be patch tested on the upper back with rubber accelerators to investigate their current degree of sensitization and the dose-response relationships.
- Conditions
- Contact Allergy
- Being tested
- Rubber accelerators and control chamber/solution for NON-SLS group, SLS, Rubber accelerators and control chamber/solution for SLS group, Patch test on back
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber accelerators and control chamber/solution for NON-SLS groupOther
Repeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms.
SLSOther
Exposure to SLS on a randomized arm
Rubber accelerators and control chamber/solution for SLS groupOther
Repeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms.
Patch test on backOther
Patch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution
| Study group | Role | What they receive |
|---|---|---|
| NON-SLS, Allergic participants | Experimental | Participants allergic to thiurams or carbamates assigned to the NON-SLS group. Receives: Other: Rubber accelerators and control chamber/solution for NON-SLS group; Other: Patch test on back |
| NON-SLS, Control participants | Experimental | Participants not allergic to thiurams or carbamates assigned to the NON-SLS group. Receives: Other: Rubber accelerators and control chamber/solution for NON-SLS group; Other: Patch test on back |
| SLS, Allergic participants | Experimental | Participants allergic to thiurams or carbamates assigned to the SLS group. Receives: Other: SLS; Other: Rubber accelerators and control chamber/solution for SLS group; Other: Patch test on back |
| SLS, Control participants | Experimental | Participants not allergic to thiurams or carbamates assigned to the SLS group. Receives: Other: SLS; Other: Rubber accelerators and control chamber/solution for SLS group; Other: Patch test on back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading of skin reactions
Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
Measured: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Skin blood flow
Changes in blood flow on the arms using laser doppler flowmetry
Measured: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start5 Feb 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact AllergyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The participants are assigned to either the SLS-group or NON-SLS-group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042309
- Sponsor's protocol ID
- H-22058515
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kursawe Larsen C, Johansen JD, Zachariae C, Svedman C, Bergendorff O, Mortz CG, Schwensen JFB. Thresholds for Contact Allergy to a Rubber Accelerator: TETD-Determined by Serial Dilution Patch Testing and a Simulated Glove-Use Model. Contact Dermatitis. 2025 Aug;93(2):138-147. doi: 10.1111/cod.14817. Epub 2025 May 16.
PubMed 40375756
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
- ClinicalTrials.gov ID
- NCT06042309
- Acronym / sponsor ID
- H-22058515
- Conditions
- Contact Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 18 Sep 2023 (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.
This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Further, it will investigate whether a damaged skin barrier as caused by wet work increase the severity of the allergic contact dermatitis.
The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.
Following this, the participants' volar forearms will be exposed to thiurams or carbamates and a control solution every night for 7 nights to simulate the repeated exposure to rubber gloves with accelerators. The skin reactions will be read cf. current international guidelines and further quantified using laser Doppler flowmetry.
During the study, all participants will be patch tested on the upper back with rubber accelerators to investigate their current degree of sensitization and the dose-response relationships.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The participants are assigned to either the SLS-group or NON-SLS-group.
| Arm | Type | Receives |
|---|---|---|
| NON-SLS, Allergic participants | Experimental | Other: Rubber accelerators and control chamber/solution for NON-SLS group, Other: Patch test on backParticipants allergic to thiurams or carbamates assigned to the NON-SLS group. |
| NON-SLS, Control participants | Experimental | Other: Rubber accelerators and control chamber/solution for NON-SLS group, Other: Patch test on backParticipants not allergic to thiurams or carbamates assigned to the NON-SLS group. |
| SLS, Allergic participants | Experimental | Other: SLS, Other: Rubber accelerators and control chamber/solution for SLS group, Other: Patch test on backParticipants allergic to thiurams or carbamates assigned to the SLS group. |
| SLS, Control participants | Experimental | Other: SLS, Other: Rubber accelerators and control chamber/solution for SLS group, Other: Patch test on backParticipants not allergic to thiurams or carbamates assigned to the SLS group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥18 years old
- Sensitized to thiurams, carbamates or both.
- Received written and oral information about the study.
- Signed written consent form
- adults ≥18 years old
Key exclusion criteria (20 listed)
- Dermatitis on back or arms
- Tattoos or significant scar tissue on exposure areas
- Pregnancy
- Breast feeding
- Recently given birth
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 |
|---|---|---|
| Rubber accelerators and control chamber/solution for NON-SLS groupRepeated exposure to rubber accelerators and control chamber/solution on arms. Three different concentrations of rubber accelerators and one control chamber/solution will be applied on the arms. | Other | NON-SLS, Allergic participants, NON-SLS, Control participants |
| SLSExposure to SLS on a randomized arm | Other | SLS, Allergic participants, SLS, Control participants |
| Rubber accelerators and control chamber/solution for SLS groupRepeated exposure to rubber accelerators and control chamber/solution on arms. Two different concentrations of rubber accelerators and one control chamber/solution will be applied on both arms. | Other | SLS, Allergic participants, SLS, Control participants |
| Patch test on backPatch test on the back with thiurams or carbamates in different concentrations and a control chamber/solution | Other | NON-SLS, Allergic participants, NON-SLS, Control participants, SLS, Allergic participants, SLS, Control participants |
Primary outcome
Reading of skin reactions
Time frame: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
Skin blood flow
Time frame: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Changes in blood flow on the arms using laser doppler flowmetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 40375756Kursawe Larsen C, Johansen JD, Zachariae C, Svedman C, Bergendorff O, Mortz CG, Schwensen JFB. Thresholds for Contact Allergy to a Rubber Accelerator: TETD-Determined by Serial Dilution Patch Testing and a Simulated Glove-Use Model. Contact Dermatitis. 2025 Aug;93(2):138-147. doi: 10.1111/cod.14817. Epub 2025 May 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLS and Patch test on back in people with Contact Allergy, run by National Allergy Research Center, Denmark at 2 sites in 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 7 inclusion and 20 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading of skin reactions (time frame: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042309, which also lists 1 linked publication.
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 17 Jan 2025.