Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-03-05 @ 11:54 AM
Study NCT ID:
NCT06897969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D013535', 'term': 'Suspensions'}, {'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'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'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vancouver Scar Score', 'timeFrame': 'Vancouver Scar score will be measured at baseline (before treatment assignment) and then 4-weeks after completion of treatment - 16-weeks after randomization.', 'description': 'The Vancouver Scar scale assesses four parameters of vascularity, pigmentation, pliability and height. The total score ranges from 0 - 13.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keloid', 'Vancouver scar scale', 'Triamcinolone', 'Verapamil', 'Intralesional injection'], 'conditions': ['Keloid Scars']}, 'referencesModule': {'references': [{'pmid': '34278918', 'type': 'BACKGROUND', 'citation': 'Kuang J, An P, Li W. Comparative efficacy and safety of verapamil and triamcinolone in keloid and hypertrophic scar treatment: a meta-analysis. J Cosmet Laser Ther. 2021 Feb 17;23(1-2):26-34. doi: 10.1080/14764172.2021.1950765. Epub 2021 Jul 18.'}, {'type': 'BACKGROUND', 'citation': 'Uzair M, Butt G, Khurshid K, Pal SS. Comparison of intralesional triamcinolone and intralesional verapamil in the treatment of keloids. Our Dermatol Online. 2015;6(3):280-4.'}, {'pmid': '30775139', 'type': 'BACKGROUND', 'citation': 'Saki N, Mokhtari R, Nozari F. Comparing the Efficacy of Intralesional Triamcinolone Acetonide With Verapamil in Treatment of Keloids: A Randomized Controlled Trial. Dermatol Pract Concept. 2019 Jan 31;9(1):4-9. doi: 10.5826/dpc.0901a02. eCollection 2019 Jan.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of intralesional triamcinolone and verapamil in patients presenting with keloid at our local setting. The results will guide us towards better management of keloids by choosing the more appropriate treatment. Adequate treatment will reduce significant emotional and physical distress in patients. We hypothesized that mean reduction in Vancouver Scar Score is higher in triamcinolone acetonide group compared to verapamil after three months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* size of keloid1-5 cm,\n* on any site of the body,\n* duration less then five years and\n* baseline Vancouver scar score of more the or equal to 5\n\nExclusion Criteria:\n\n* Pregnant or lactating women,\n* family history of keloids,\n* acromegaly, and\n* congestive cardiac diseases'}, 'identificationModule': {'nctId': 'NCT06897969', 'briefTitle': 'Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Nishtar Medical University'}, 'officialTitle': 'Comparison of Intralesional Triamcinolone and Intralesional Verapamil in the Treatment of Keloids', 'orgStudyIdInfo': {'id': '21467/NMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verapamil Treatment', 'description': 'One ml (2.5 mg) of Intralesional Verapamil Injection will be administered monthly. The injections will be administered with an insulin syringe of 27-gauge needle. Administration of the treatment medication will be continued till the keloid is flattened or TOTAL DURATION of three months.', 'interventionNames': ['Drug: Verapamil Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Triamcinolone Treatment', 'description': 'Intralesional Triamcinolone acetonide (40mg) will be administered monthly. The injections will be administered with an insulin syringe of 27-gauge needle. Administration of the treatment medication will be continued till the keloid is flattened or TOTAL DURATION of three months.', 'interventionNames': ['Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension']}], 'interventions': [{'name': 'Triamcinolone Acetonide 1 ml of 40 mg/mL suspension', 'type': 'DRUG', 'description': 'Monthly intralesional injection', 'armGroupLabels': ['Triamcinolone Treatment']}, {'name': 'Verapamil Injection', 'type': 'DRUG', 'description': '2.5 mg of intralesional Verapamil injection monthly', 'armGroupLabels': ['Verapamil Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Dr. Asma Batool, MBBS', 'role': 'CONTACT', 'email': 'abatool709@gmail.com', 'phone': '0923470416435'}, {'name': 'Dr. Asma Batool, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nishtar Medical University & Hospital', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'centralContacts': [{'name': 'Dr. Asma Batool, MBBS', 'role': 'CONTACT', 'email': 'abatool709@gmail.com', 'phone': '923470416435'}], 'overallOfficials': [{'name': 'Dr. Aliya Akhtar, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nishtar Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared to protect patient confidentiality and comply with ethical and regulatory guidelines. Additionally, the study design does not include provisions for public data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nishtar Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Asma Batool', 'investigatorAffiliation': 'Nishtar Medical University'}}}}