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

NCT ID: NCT03313232

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2018-04-09

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

Conditions

Allergic Contact Dermatitis Due to Cosmetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Fragrance allergic patients

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.

Group Type: EXPERIMENTAL

ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%

Intervention Type: OTHER

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

Possible fragrance allergic patients

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.

Group Type: EXPERIMENTAL

ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%

Intervention Type: OTHER

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

Healty controls

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.

Group Type: EXPERIMENTAL

ROAT with oxidized R-limonene at 1%

Intervention Type: OTHER

A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niels Højsager Bennike

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Dermatology and Allergy, Gentofte University Hospital

Hellerup, DK, Denmark

Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital

Gothenburg, SE, Sweden

Countries

Denmark; Sweden

Other Identifiers

HGH-2017-017

Identifier Type: -

Identifier Source: org_study_id