Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:52 PM
Study NCT ID:
NCT04442633
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2020-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glutamine With Topical Corticosteroids for Lichen Planus Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'C056627', 'term': 'Orabase'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in oral lichen planus lesions severity', 'timeFrame': 'at baseline, 1 months and 3 months', 'description': 'Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion'}], 'secondaryOutcomes': [{'measure': 'Change in pain level', 'timeFrame': 'at baseline, 1 months and 3 months', 'description': 'Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lichen Penis Planus']}, 'descriptionModule': {'briefSummary': 'Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.', 'detailedDescription': 'Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.\n\nThe aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.\n\nThirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients clinically and histopathologically diagnosed to be suffering from EOLP.\n2. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.\n3. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire\n4. Males and Females with an age ranging from 30-60years\n\nExclusion Criteria:\n\n1. Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.\n2. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)\n3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.'}, 'identificationModule': {'nctId': 'NCT04442633', 'briefTitle': 'Glutamine With Topical Corticosteroids for Lichen Planus Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus', 'orgStudyIdInfo': {'id': 'Glutamine and lichen planus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional therapy', 'description': 'topical corticosteroid plus antifungal', 'interventionNames': ['Drug: Miconazole Oral gel', 'Drug: Kenacort in orabase']}, {'type': 'EXPERIMENTAL', 'label': 'Glutamine with a topical corticosteroid plus antifungal', 'description': 'Glutamine therapy in combination with a topical corticosteroid plus antifungal', 'interventionNames': ['Drug: Glutamine Cap/Tab', 'Drug: Miconazole Oral gel', 'Drug: Kenacort in orabase']}], 'interventions': [{'name': 'Glutamine Cap/Tab', 'type': 'DRUG', 'description': 'Glutamine Capsules: One capsule three times daily on an empty stomach for one month', 'armGroupLabels': ['Glutamine with a topical corticosteroid plus antifungal']}, {'name': 'Miconazole Oral gel', 'type': 'DRUG', 'description': 'Miconazole oral gel: applied three to four times daily for three weeks', 'armGroupLabels': ['Glutamine with a topical corticosteroid plus antifungal', 'conventional therapy']}, {'name': 'Kenacort in orabase', 'type': 'DRUG', 'description': 'Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached', 'armGroupLabels': ['Glutamine with a topical corticosteroid plus antifungal', 'conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}