NCT03313232

Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study

Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Allergic Contact Dermatitis Due to Cosmetics

Interventions

Type	Name	Description
OTHER	ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%	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
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 a 1% concentration

Timeline

• Start date: 2017-10-10
• Primary completion: 2018-04-09
• Completion: 2018-04-09
• First posted: 2017-10-18
• Last updated: 2018-04-10

Locations

2 sites across 2 countries: Denmark, Sweden