Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-01 @ 5:04 AM
Study NCT ID:
NCT01430533
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2011-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2011-09-06', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'skin sensitization reaction', 'timeFrame': 'day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)', 'description': 'skin reactions will be assessed, using a standardized scoring scale'}]}, 'conditionsModule': {'keywords': ['dermal sensitization potential'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.', 'detailedDescription': 'In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* male or female subjects\n* aged 18 - 65 years\n* ability to understand and fulfill the study requirements\n\nExclusion Criteria:\n\n* affected skin in designated test area\n* pregnancy or lactation\n* not willing to comply with study requirements'}, 'identificationModule': {'nctId': 'NCT01430533', 'briefTitle': 'Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design', 'orgStudyIdInfo': {'id': '15854'}, 'secondaryIdInfos': [{'id': '1401842', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'Topical application of verum (azelaic acid pre foam formulation) on the skin', 'interventionNames': ['Drug: azelaic acid pre foam formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Topical application of vehicle formulation (same as verum but without active drug substance) on the skin', 'interventionNames': ['Drug: Vehicle pre foam formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control', 'description': 'Topical application of distilled water (negative control) on the skin', 'interventionNames': ['Drug: Water']}], 'interventions': [{'name': 'azelaic acid pre foam formulation', 'type': 'DRUG', 'armGroupLabels': ['Verum']}, {'name': 'Vehicle pre foam formulation', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}, {'name': 'Water', 'type': 'DRUG', 'armGroupLabels': ['Negative control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Robert I. Cooper, MD', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}