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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Hellerup, DK, Denmark, 2900
      • Department of Dermatology and Allergy, Gentofte University Hospital
• Sweden
  • SE
    • Göteborg, SE, Sweden, 41345
      • Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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
EXPERIMENTAL: 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.	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
EXPERIMENTAL: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive ROAT (minimum score of 5)	Proportion (%) of participants with a positive ROAT	Day (D) 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal eliciting concentration (MEC)	Threshold concentration for a positive patch test	Day (D) 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidermal inflammatory markers	Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas	Positive ROAT or Day (D) 21

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Göteborg University; University of Copenhagen; Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2017
• Primary Completion (ACTUAL): April 9, 2018
• Study Completion (ACTUAL): April 9, 2018

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (ACTUAL): October 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: HGH-2017-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No