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
52 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.
This study's enrollment of 48 is close to the median of 45 across 41 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Dermatitis, Allergic Contact →
Herlev and Gentofte Hospital