Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT03313232
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Epidermal inflammatory markers', 'timeFrame': 'Positive ROAT or Day (D) 21', 'description': 'Levels of inflammatory markers (e.g. IL-1beta) from tape stripping of ROAT test areas'}], 'primaryOutcomes': [{'measure': 'Positive ROAT (minimum score of 5)', 'timeFrame': 'Day (D) 21', 'description': 'Proportion (%) of participants with a positive ROAT'}], 'secondaryOutcomes': [{'measure': 'Minimal eliciting concentration (MEC)', 'timeFrame': 'Day (D) 7', 'description': 'Threshold concentration for a positive patch test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Contact Dermatitis Due to Cosmetics']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Aged 18 years or older\n* Received written and verbal information on the study.\n* Signed written consent form.\n\nExclusion Criteria:\n\n* Active eczema in test areas.\n* Pregnancy or breast feeding.\n* Treatment with topical corticosteroids or other immune-suppressants on/near test areas within two weeks prior to study start.\n* Systemic immune-suppressant treatment within seven days prior to study start.\n* UV exposure of test areas within three weeks prior to study start.\n* Unable to cooperate or communicate with the investigators.'}, 'identificationModule': {'nctId': 'NCT03313232', 'briefTitle': 'Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study', 'orgStudyIdInfo': {'id': 'HGH-2017-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fragrance allergic patients', '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.', 'interventionNames': ['Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'Possible fragrance allergic patients', '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.', 'interventionNames': ['Other: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'Healty controls', '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.', 'interventionNames': ['Other: ROAT with oxidized R-limonene at 1%']}], 'interventions': [{'name': 'ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%', 'type': 'OTHER', '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', 'armGroupLabels': ['Fragrance allergic patients', 'Possible fragrance allergic patients']}, {'name': 'ROAT with oxidized R-limonene at 1%', 'type': 'OTHER', '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', 'armGroupLabels': ['Healty controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'DK', 'country': 'Denmark', 'facility': 'Department of Dermatology and Allergy, Gentofte University Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '41345', 'city': 'Gothenburg', 'state': 'SE', 'country': 'Sweden', 'facility': 'Department of Occupational and Environmental Dermatology, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Niels Højsager Bennike', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}