Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-03 @ 9:58 AM
Study NCT ID:
NCT00484250
Status:
COMPLETED
Last Update Posted:
2007-06-11
First Post:
2007-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-08', 'studyFirstSubmitDate': '2007-06-07', 'studyFirstSubmitQcDate': '2007-06-07', 'lastUpdatePostDateStruct': {'date': '2007-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral Lichen Planus', 'Metronidazole', 'Doxycycline'], 'conditions': ['Oral Lichen Planus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.emedicine.com/derm/topic663.htm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local irritation,discomfort and subsequent poor dentition and discomfort in eating . Various treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact that steroids have been the main therapeutic choice for many years,some researches have been done regarding the efficacy of other medication such as metronidazole and doxycycline.The purpose of this study is to determine whether metronidazole and doxycycline are effective in the treatment of oral lichen planus and to compare their efficacy with each other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a biopsy-proven untreated OLP of every type with no symptom.\n\nExclusion Criteria:\n\n* pregnancy, presence of dysplasia in lesions,unilateral lesion suspected lichenoid reaction,history of drinking alcohol in at least 1 month prior to the study, smoking, systemic disease, use of systemic medications and hypersensitivity to the metronidazole and doxycycline.'}, 'identificationModule': {'nctId': 'NCT00484250', 'briefTitle': 'Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '240'}}, 'armsInterventionsModule': {'interventions': [{'name': 'metronidazole,doxycycline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91375345', 'city': 'Mashhad', 'state': 'Khorasan', 'country': 'Iran', 'facility': 'Mashhad University Of Medical Sciences(Dentistry School)', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Arash Mansourian, DDS,MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Tehran University of Medical Sciences'}, {'name': 'Majid Sanatkhani, DDS,MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mashhad University of Medical Sciences'}, {'name': 'Fatemeh Momen Heravi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}}}}