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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Page 1 of 1 (2 locations)

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