Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-01 @ 11:59 AM
Study NCT ID:
NCT00098358
Status:
UNKNOWN
Last Update Posted:
2007-02-07
First Post:
2004-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063449', 'term': 'zileuton'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-11'}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2007-02-05', 'studyFirstSubmitDate': '2004-12-07', 'studyFirstSubmitQcDate': '2004-12-07', 'lastUpdatePostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of inflammatory lesions'}], 'secondaryOutcomes': [{'measure': "Physician's global assessment scale"}, {'measure': 'Change in number of non-inflammatory lesions'}, {'measure': 'Change in total numbers of lesions'}, {'measure': 'Change in sebum production'}]}, 'conditionsModule': {'keywords': ['Leukotrienes', 'inflammation'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '12756111', 'type': 'BACKGROUND', 'citation': 'Zouboulis CC, Nestoris S, Adler YD, Orth M, Orfanos CE, Picardo M, Camera E, Cunliffe WJ. A new concept for acne therapy: a pilot study with zileuton, an oral 5-lipoxygenase inhibitor. Arch Dermatol. 2003 May;139(5):668-70. doi: 10.1001/archderm.139.5.668. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe facial acne vulgaris\n* 20 to 60 facial inflammatory lesions\n* 10 to 200 facial non-inflammatory lesions\n* No more than 3 facial nodular cystic lesions\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* Use of systemic or topical acne therapy within 14 days of study\n* Use of systemic retinoids within past 2 years\n* Skin diseases that interfere with acne counts\n* Active liver disease\n* Screening elevations in liver function tests\n* Positive serology for hepatitis B or C\n* Use of theophylline, warfarin, or propranolol within 7 days of study\n* Use of Singulair or Accolate within 14 days of study\n* Female patients who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT00098358', 'briefTitle': 'Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Critical Therapeutics'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CTI-02-C04-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zileuton', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'MedaPhase, Inc.', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists, PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Dermatology Associates of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '17033-0850', 'city': 'Hersey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S. Hersey Medical Center'}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Rivergate Dermatology', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies, Inc.', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Walter Newman, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Critical Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Critical Therapeutics', 'class': 'INDUSTRY'}}}}