Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06981767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of 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': 'D001963', 'term': 'Bromelains'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'C056627', 'term': 'Orabase'}], 'ancestors': [{'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': 'Recorded at baseline, and weekly for 4 weeks', 'description': 'Clinical improvement will be measured using Thongprasom et al. scoring system. In Thongprasom et al. scale, lesions are given score as follows: 0, no lesions, normal mucosa; 1, Mild white striae, no erythematous area; 2, White striae with atrophic area \\< 1 cm2; 3, White striae with atrophic area \\> 1 cm2; 4, White striae with erosive area \\< 1 cm2 and 5, White striae with erosive area \\> 1 cm2 (Thongprasom et al., 2003).'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'baseline, daily for the first week, then weekly for the remaining 3 weeks.', 'description': 'Pain intensity will be measured using Visual analogue scale (VAS), VAS is a self-reported pain score ranging from 0 to 10 (Cheng et al., 2012) at baseline, daily for the first week, then weekly for the remaining 3 weeks.'}, {'measure': 'Oral health-related quality of life', 'timeFrame': 'at baseline, and weekly for the 4 weeks.', 'description': "Oral health-related quality of life using Oral Health Impact Profile-14 (OHIP-14) Oral health-related quality of life is a five-point Likert-type scale used in scoring each item of the OHIP-14. Responses are coded 0 = never', 1 = hardly ever', 2 = occasionally', 3 = fairly often', 4 = very often'. Item responses are summed to produce an OHIP-14 total score. Total OHIP-14 scores range from 0 (no impact) to 56 (all of the oral health problems are experienced very often). High scores indicates a poor oral health-related quality of life (Wiriyakijja et al., 2018)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus']}, 'descriptionModule': {'briefSummary': 'Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from symptomatic OLP\n* Patients free from any visible oral lesions other than OLP.\n* Patients who agreed to take the supplied interventions.\n* Patient who will agree to participate in the study.\n* Patients who will accept to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients suffering from any systemic disease.\n* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.\n* Treatment with any oral topical medications for at least four weeks prior to the study.\n* Pregnant and lactating mothers.'}, 'identificationModule': {'nctId': 'NCT06981767', 'briefTitle': 'Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Bromelain in Orabase', 'description': 'Participants in this group will receive topical bromelain incorporated into an orabase.\n\nPatients will be instructed to apply the formulation four times daily No additional topical medications will be permitted.', 'interventionNames': ['Dietary Supplement: Topical Bromelain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Triamcinolone Acetonide in Orabase', 'description': 'This group will receive topical 0.1% triamcinolone acetonide The treatment will be applied four times daily, following the same instructions and precautions as in Arm 1', 'interventionNames': ['Drug: 0.1% topical triamcinolone acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase', 'description': 'Participants in this arm will be treated with a combination formulation containing both topical bromelain and 0.1% triamcinolone acetonide in orabase.\n\nApplication instructions will be identical to those in the other arms: four times daily.', 'interventionNames': ['Combination Product: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase']}], 'interventions': [{'name': 'Topical Bromelain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A natural enzyme-based formulation derived from pineapple, bromelain in orabase is being investigated for its anti-inflammatory and wound-healing properties. As a non-steroidal alternative, it offers a potentially safer treatment option with minimal side effects.', 'armGroupLabels': ['Topical Bromelain in Orabase']}, {'name': '0.1% topical triamcinolone acetonide', 'type': 'DRUG', 'description': 'A corticosteroid-based standard treatment for OLP, triamcinolone acetonide in orabase is used for its strong anti-inflammatory and immunosuppressive effects. It serves as the conventional treatment versus novel therapy in this study', 'armGroupLabels': ['Topical Triamcinolone Acetonide in Orabase']}, {'name': 'Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase', 'type': 'COMBINATION_PRODUCT', 'description': 'This novel formulation combines the enzymatic, healing properties of bromelain with the anti-inflammatory property of triamcinolone. It is designed to provide enhanced therapeutic effects through synergistic action, potentially reducing the required corticosteroid dose while improving clinical outcomes.', 'armGroupLabels': ['Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's Student in Oral Medicine", 'investigatorFullName': 'Lujain Taleb Suleiman Aladwan', 'investigatorAffiliation': 'Cairo University'}}}}