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

Primary Purpose

Allergic Contact Dermatitis Due to Cosmetics

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%
ROAT with oxidized R-limonene at 1%
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Contact Dermatitis Due to Cosmetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Dermatology and Allergy, Gentofte University Hospital
  • Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Fragrance allergic patients

Possible fragrance allergic patients

Healty controls

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Positive ROAT (minimum score of 5)
Proportion (%) of participants with a positive ROAT

Secondary Outcome Measures

Minimal eliciting concentration (MEC)
Threshold concentration for a positive patch test

Full Information

First Posted
October 3, 2017
Last Updated
April 9, 2018
Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen, Sahlgrenska University Hospital, Sweden, Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03313232
Brief Title
Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
Official Title
Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
University of Copenhagen, Sahlgrenska University Hospital, Sweden, Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis Due to Cosmetics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fragrance allergic patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Possible fragrance allergic patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healty controls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%
Intervention Description
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
Intervention Name(s)
ROAT with oxidized R-limonene at 1%
Intervention Description
A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration
Primary Outcome Measure Information:
Title
Positive ROAT (minimum score of 5)
Description
Proportion (%) of participants with a positive ROAT
Time Frame
Day (D) 21
Secondary Outcome Measure Information:
Title
Minimal eliciting concentration (MEC)
Description
Threshold concentration for a positive patch test
Time Frame
Day (D) 7
Other Pre-specified Outcome Measures:
Title
Epidermal inflammatory markers
Description
Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas
Time Frame
Positive ROAT or Day (D) 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Department of Dermatology and Allergy, Gentofte University Hospital
City
Hellerup
State/Province
DK
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital
City
Göteborg
State/Province
SE
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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