Clinical evaluation of the 3 allergens: Methyldibromoglutharonitrile, Parthenolide and Goldsodiumthiosulphate for "TRUE Test Panel 3" - a phase II, dose-response study.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004899-36-SE

Enrollment

Registered

2004-12-16

Start date

2005-02-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of Allergic Contact Dermatitis.

Interventions

Trade Name: Will be included in the TRUE Test Product Name: TRUE Test Pharmaceutical Form: Cutaneous stick INN or Proposed INN: Methyldibromoglutharonitrile CAS Number: 35691-65-7 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.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. 2. Age more than or equal to 18 years. 3. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area. 2. Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days. 4. Treatment with UV-light during the latest 3 weeks. 5. Widespread active dermatitis or dermatitis on test area. 6. Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the test should be postponed. 7. Subjects not able to cooperate. 8. Participation in other clinical studies during the study period and 3 weeks prior to study start.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the optimum concentration of the 3 patches: Methyldibromoglutharonitrile, Parthenolide and Goldsodiumthiosulphate.;Secondary Objective: Safety To evaluate the 2 vehicles PVP and HPC for the Methyldibromoglutharonitrile patch.;Primary end point(s): To establish the optimum dose/concentration of a MDBGN-patch, a Parthenolide-patch and a Goldnatriumthiosulphate-patch for a third TRUE Test® Panel	—

Measure

Time frame

Main Objective: To establish the optimum concentration of the 3 patches: Methyldibromoglutharonitrile, Parthenolide and Goldsodiumthiosulphate.;Secondary Objective: Safety To evaluate the 2 vehicles PVP and HPC for the Methyldibromoglutharonitrile patch.;Primary end point(s): To establish the optimum dose/concentration of a MDBGN-patch, a Parthenolide-patch and a Goldnatriumthiosulphate-patch for a third TRUE Test® Panel

—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026