Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
Allergic Contact Dermatitis Due to Cosmetics
About this trial
This is an interventional diagnostic trial for Allergic Contact Dermatitis Due to Cosmetics
Eligibility Criteria
Inclusion Criteria:
- Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.
- Aged 18 years or older
- Received written and verbal information on the study.
- Signed written consent form.
Exclusion Criteria:
- Active eczema in test areas.
- Pregnancy or breast feeding.
- Treatment with topical corticosteroids or other immune-suppressants on/near test areas within two weeks prior to study start.
- Systemic immune-suppressant treatment within seven days prior to study start.
- UV exposure of test areas within three weeks prior to study start.
- Unable to cooperate or communicate with the investigators.
Sites / Locations
- Department of Dermatology and Allergy, Gentofte University Hospital
- Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Fragrance allergic patients
Possible fragrance allergic patients
Healty controls
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.
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.
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.