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

Not Applicable

Completed

• Conditions: Allergic Contact Dermatitis Due to Cosmetics
• Interventions: Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%; Other: ROAT with oxidized R-limonene at 1%

• Registration Number: NCT03313232
• Lead Sponsor: Herlev and Gentofte Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-03
• Study Start: 2017-10-10
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-18
• Status Verified: 2018-04
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Possible fragrance allergic patients	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.
Fragrance allergic patients	ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%	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.
Healty controls	ROAT with oxidized R-limonene at 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.

Primary Outcome Measures

Name	Time	Method
Positive ROAT (minimum score of 5)	Day (D) 21	Proportion (%) of participants with a positive ROAT

Secondary Outcome Measures

Name	Time	Method
Minimal eliciting concentration (MEC)	Day (D) 7	Threshold concentration for a positive patch test

Trial Locations

Locations (2)

Department of Dermatology and Allergy, Gentofte University Hospital; 🇩🇰 Hellerup, DK, Denmark

Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital; 🇸🇪 Göteborg, SE, Sweden