Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 8:42 AM
Study NCT ID:
NCT00680095
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2008-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cumulative Irritation Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512998', 'term': 'tavaborole'}, {'id': 'D012967', 'term': 'Sodium Dodecyl Sulfate'}], 'ancestors': [{'id': 'D007851', 'term': 'Dodecanol'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2007-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-15', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe irritation (Grade 3 or 4) observed at any site', 'timeFrame': 'Daily for 21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Onychomycosis', 'Fungal Nail'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.', 'detailedDescription': 'Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, volunteers of either sex, at least 18 years of age or older\n* Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active\n* Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions\n* Subjects were willing to follow the study procedures and complete the study\n* Written informed consent was obtained\n\nExclusion Criteria:\n\n* Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded\n* Subject was pregnant or nursing\n* Subject had a history of sensitivity to any component of any of the formulations\n* Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study'}, 'identificationModule': {'nctId': 'NCT00680095', 'briefTitle': 'Cumulative Irritation Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '21-day Cumulative Irritation Test', 'orgStudyIdInfo': {'id': 'AN2690-ONYC-101'}, 'secondaryIdInfos': [{'id': 'C3371011', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'AN2690 Solution, 2.5%', 'interventionNames': ['Drug: AN2690']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'AN2690 Solution, 7.5%', 'interventionNames': ['Drug: AN2690']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'AN2690 Solution, 5.0%', 'interventionNames': ['Drug: AN2690']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D', 'description': 'AN2690 Solution, Vehicle', 'interventionNames': ['Other: AN2690 Solution, Vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'E', 'description': 'Sodium Lauryl Sulfate, 0.5%', 'interventionNames': ['Other: Sodium Lauryl Sulfate, 0.5%']}], 'interventions': [{'name': 'AN2690', 'type': 'DRUG', 'description': 'AN2690 Solution, 2.5%, Daily for up to 21 days', 'armGroupLabels': ['A']}, {'name': 'AN2690', 'type': 'DRUG', 'description': 'AN2690 Solution, 7.5%, Daily for up to 21 days', 'armGroupLabels': ['B']}, {'name': 'AN2690', 'type': 'DRUG', 'description': 'AN2690 Solution, 5.0%, Daily for up to 21 days', 'armGroupLabels': ['C']}, {'name': 'AN2690 Solution, Vehicle', 'type': 'OTHER', 'description': 'AN2690 Solution, Vehicle, Daily for up to 21 days', 'armGroupLabels': ['D']}, {'name': 'Sodium Lauryl Sulfate, 0.5%', 'type': 'OTHER', 'description': 'Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education and Research Foundation, Inc.', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}