An interventional study of ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% and ROAT with oxidized R-limonene at 1% in Allergic Contact Dermatitis Due to Cosmetics, sponsored by Herlev and Gentofte Hospital. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Diagnostic
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
Exclusion Criteria:
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.
Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%
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.
Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%
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.
Other: ROAT with oxidized R-limonene at 1%
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
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration
Positive ROAT (minimum score of 5)
Proportion (%) of participants with a positive ROAT
Time frame: Day (D) 21
Minimal eliciting concentration (MEC)
Threshold concentration for a positive patch test
Time frame: Day (D) 7
Epidermal inflammatory markers
Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas
Time frame: Positive ROAT or Day (D) 21
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Herlev and Gentofte Hospital