Status:
COMPLETED
Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
Lead Sponsor:
Herlev and Gentofte Hospital
Collaborating Sponsors:
University of Copenhagen
Sahlgrenska University Hospital
Conditions:
Allergic Contact Dermatitis Due to Cosmetics
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03313232
Start Date
October 10 2017
End Date
April 9 2018
Last Update
April 10 2018
Active Locations (2)
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1
Department of Dermatology and Allergy, Gentofte University Hospital
Hellerup, DK, Denmark, 2900
2
Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital
Gothenburg, SE, Sweden, 41345