Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-28 @ 2:01 PM
Study NCT ID:
NCT02106468
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2014-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus
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': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-26', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve quality of the life (Oral Health Impact Profile)', 'timeFrame': '6 months', 'description': 'Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.'}], 'secondaryOutcomes': [{'measure': 'Size and types (atrophic/erosive) of the lesions', 'timeFrame': '6 months', 'description': 'Size and types of the lesions were examined at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy.\n\nScore 5 = white striae with erosive area more than I cm Score 4 = white striae with erosive area less than 1 cm Score 3 = white striae with atrophic area more than I cm Score 2 = white striae with atrophic area less than I cm Score I =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa'}, {'measure': 'Pain score (Visual analogue scale (VAS)),', 'timeFrame': '6 months', 'description': 'Pain score was recorded at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy.\n\nScale 0: no pain: VAS=0 Scale 1: mild pain: 0\\< VAS≤3.5 Scale 2: moderate pain: 3.5 \\<VAS≤7 Scale 3: severe pain: 7\\< VAS≤10.'}, {'measure': 'Recurrence of disease', 'timeFrame': '3 months', 'description': 'Recurrence within the following 3 months was recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral Lichen Planus', 'Corticosteroid', 'Omega -3'], 'conditions': ['Oral Lichen Planus']}, 'descriptionModule': {'briefSummary': 'This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).\n2. Age between 30-60 years\n3. Ability to complete the present clinical trial.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding women (pregnancy test for women of child bearing age).\n2. Lichenoid reactions caused by certain drugs or dental amalgam.\n3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study.\n4. Patient doesn't have hepatitis C \\[after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2\n5. Presence of candidiasis before treatment.\n6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.\n7. Hypertensive patients\n8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations)."}, 'identificationModule': {'nctId': 'NCT02106468', 'briefTitle': 'The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study', 'orgStudyIdInfo': {'id': 'Elgendy - 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prednisone 50 mg tablet', 'description': 'This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.', 'interventionNames': ['Drug: Prednisone tablet 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3 capsules 1000 mg', 'description': 'This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.', 'interventionNames': ['Drug: Omega-3 soft capsules 1000 mg']}], 'interventions': [{'name': 'Prednisone tablet 5mg', 'type': 'DRUG', 'otherNames': ['Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy'], 'description': 'This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.', 'armGroupLabels': ['prednisone 50 mg tablet']}, {'name': 'Omega-3 soft capsules 1000 mg', 'type': 'DRUG', 'otherNames': ['Super Omega; Technopharma, Cairo, Egypt'], 'description': 'This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.', 'armGroupLabels': ['Omega-3 capsules 1000 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'October 6 University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Enas Elgendy, ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'October 6 University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecuture, October 6 University', 'investigatorFullName': 'Enas Elgendy', 'investigatorAffiliation': 'October 6 University'}}}}