Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT05139667
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral 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': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'oral lichen planus'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'treatment of oral lichen planus'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical score', 'timeFrame': 'change from baseline at 12 weeks', 'description': '"0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area'}], 'secondaryOutcomes': [{'measure': 'caspase-3', 'timeFrame': 'change from base line at 8 weeks', 'description': 'caspase-3 cells count in immunostained section'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus']}, 'referencesModule': {'references': [{'pmid': '36788511', 'type': 'DERIVED', 'citation': 'Ibrahim SS, Ragy NI, Nagy NA, El-Kammar H, Elbakry AM, Ezzatt OM. Evaluation of muco-adhesive tacrolimus patch on caspase-3 induced apoptosis in oral lichen planus: a randomized clinical trial. BMC Oral Health. 2023 Feb 14;23(1):99. doi: 10.1186/s12903-023-02803-8.'}]}, 'descriptionModule': {'briefSummary': 'tacrolimus has been widely used as an immunosuppressant. the objective of this study was to evaluate the clinical efficacy of tacrolimus 0.1 % in muco adhesive patch compared to tacrolimus or corticosteroids in paste forms for symptomatic oral lichen planus, and to investigate the effect of topical tacrolimus or corticosteroids on the expression of caspase-3 in oral lichen planus as an early marker of apoptosis using immunohistochemically analysis', 'detailedDescription': 'thirty patients with erosive or atrophic OLP were randomly assigned into three equal groups to receive topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 1), tacrolimus paste 0.1% four times per day ( Group 2) , and tacrolimus patch 2 times per day ( Group 3). all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were immunohistochemically stained to detect expression of caspase-3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically and histologically proven painful bullous/erosive or atrophic forms of OLP\n\nExclusion Criteria:\n\n* lichenoid lesions smoking systemic conditions pregnancy or breast feeding known hypersnstivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation'}, 'identificationModule': {'nctId': 'NCT05139667', 'briefTitle': 'Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus ( A Randomized Controlled Clinical Trial With Immunohistochemical Analysis)', 'orgStudyIdInfo': {'id': 'FDASU-RECD123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tacrolimus/corticosteroid', 'description': 'topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch', 'interventionNames': ['Drug: Corticosteroid Topical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'corticosteroids', 'description': 'topical corticosteroid', 'interventionNames': ['Drug: Corticosteroid Topical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tacrolimus', 'description': 'topical tacrolimus patch and tacrolimus paste', 'interventionNames': ['Drug: Corticosteroid Topical']}], 'interventions': [{'name': 'Corticosteroid Topical', 'type': 'DRUG', 'otherNames': ['tacrolimus paste and patch topical'], 'description': 'topical tacrolimus and corticosteroids', 'armGroupLabels': ['corticosteroids', 'tacrolimus', 'tacrolimus/corticosteroid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Noha Dawoud', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of oral medicine and diagnosis', 'investigatorFullName': 'Noha Dawoud', 'investigatorAffiliation': 'Ain Shams University'}}}}