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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Göteborg University | OTHER |
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This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fragrance allergic patients | Experimental | Patients with a previous positive patch test to oxidized R-Limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. |
|
| Possible fragrance allergic patients | Experimental | Patients with a previous doubtful patch test to oxidized R-limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks. |
|
| Healty controls | Experimental | Healthy controls with no contact allergy to oxidized R-limonene. Healthy controls will have en initial diagnostic patch test with oxidized R-limonene performed followed by twice daily exposure to oxidized R-limonene at one concentration and a vehicle control on the forearms for up to three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% | Other | A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at 1%, 0.3% and 0.1% concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| Positive ROAT (minimum score of 5) | Proportion (%) of participants with a positive ROAT | Day (D) 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal eliciting concentration (MEC) | Threshold concentration for a positive patch test | Day (D) 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Epidermal inflammatory markers | Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas | Positive ROAT or Day (D) 21 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology and Allergy, Gentofte University Hospital | Hellerup | DK | 2900 | Denmark | ||
| Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital |
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| ROAT with oxidized R-limonene at 1% | Other | A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration |
|
| Gothenburg |
| SE |
| 41345 |
| Sweden |