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

NCT03313232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-10

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Herlev and Gentofte Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-04-09
Completion
2018-04-09

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313232 on ClinicalTrials.gov