Allergic Contact DermatitisPhase 2NCT00133341
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
A Phase 2 study testing Goldnatriomthiosulphate, MDBGN, parthenolide in people with Allergic Contact Dermatitis, run by Mekos Laboratories AS at 1 site in Denmark.
Trial summary
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Goldnatriomthiosulphate, MDBGN, parthenolide
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
- Age more or equal to 18 years.
- Signed informed consent.
Who cannot join
- Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
- Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
- Treatment with UV-light during the latest 3 weeks.
- Widespread active dermatitis or dermatitis on test area.
- Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
- Subjects not able to cooperate.
- Participation in other clinical studies during the study period and 3 weeks prior to study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for "TRUE Test® Panel 3" - a Phase II, Dose-Response Study.
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
Read the detailed description
The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Goldnatriomthiosulphate, MDBGN, parthenolide
- Keywords
- Allergic contact dermatitis,patch testing, dilution series
- 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.
Goldnatriomthiosulphate, MDBGN, parthenolideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary outcomes (1)
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Mekos Laboratories AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus E Andersen, Prof., Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133341
- Sponsor's protocol ID
- MEKOS 05 P379/1
- Status last verified
- Feb 2006
- First submitted
- 22 Aug 2005
- Last updated
- 27 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for "TRUE Test® Panel 3" - a Phase II, Dose-Response Study.
- ClinicalTrials.gov ID
- NCT00133341
- Acronym / sponsor ID
- MEKOS 05 P379/1
- Conditions
- Allergic Contact Dermatitis
- Keywords
- Allergic contact dermatitis,patch testing, dilution series
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Mekos Laboratories ASIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Dec 2005
- First posted
- 23 Aug 2005 (estimated)
- 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.
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
Detailed description
The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
- Age more or equal to 18 years.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
- Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
- Treatment with UV-light during the latest 3 weeks.
- Widespread active dermatitis or dermatitis on test area.
- Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
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 |
|---|---|---|
| Goldnatriomthiosulphate, MDBGN, parthenolide | Drug | – |
Primary outcome
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
1 secondary outcome
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
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 27 Feb 2006.
- Sponsor's homepageLink provided by the sponsor.
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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.
Klaus E Andersen, Prof. principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Goldnatriomthiosulphate, MDBGN, parthenolide in people with Allergic Contact Dermatitis, run by Mekos Laboratories AS at 1 site 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 3 inclusion and 7 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 27 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade). 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 27 Feb 2006.