Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:49 AM
Study NCT ID:
NCT07420166
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intralesional Triamcinolone Acetonide Treatment With Intralesional Verapamil Hydrochloride in Keloids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': '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': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar assessment', 'timeFrame': '24 weeks', 'description': 'Using the Vancouver Scar Scale, height, vascularity, pliability, and pigmentation were assessed at baseline and compared with post-treatment measures at 24 weeks. A score closer to 0 was deemed as better vascularity (not red), low pigmentation, high pliability (soft), and low thickness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keloid']}, 'descriptionModule': {'briefSummary': 'The paucity of local literature regarding the comparison of intralesional verapamil with intralesional triamcinolone acetonide led this study to be carried out with the objective of comparing the clinical effectiveness of intralesional triamcinolone acetonide and intralesional verapamil hydrochloride in patients with keloids.', 'detailedDescription': 'Although the anti-inflammatory and scar-enhancing properties of corticosteroids on hypertrophic scars and keloids have been investigated and documented thoroughly. There are many different treatments for keloids nowadays; each method has its advantages and disadvantages, and the results also vary depending on each study. Moreover, local data to address this issue is also scarce. The findings of this study would not add to the existing stats, but comparing the outcomes of both the drugs would also guide clinicians towards better management of keloids by choosing the more appropriate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either gender\n* Aged between 20 and 60 years\n* With keloids\n* Benign dermal growths\n* Scar length not exceeding 5 centimeters\n* Keloid duration of five years or less\n* A baseline Vancouver Scar Scale score of 5 or more\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* A family history of keloids\n* Diagnosed with conditions such as acromegaly, diabetes mellitus, or congestive cardiac disease\n* a history of thyroidectomy\n* Current or recent use of isotretinoin or anabolic steroids, as determined by history, physical examination, blood glucose analysis, and electrocardiography'}, 'identificationModule': {'nctId': 'NCT07420166', 'briefTitle': 'Comparison of Intralesional Triamcinolone Acetonide Treatment With Intralesional Verapamil Hydrochloride in Keloids', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparison of the Outcome of Treatment of Intralesional Triamcinolone Acetonide With Intralesional Verapamil Hydrochloride in Patients Presenting With Keloid at Tertiary Care Hospital, Bahawalpur.', 'orgStudyIdInfo': {'id': 'Dr-Bakhtawar-BVH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triamcinolone Group', 'description': 'Patients received intralesional triamcinolone acetonide (20 mg/mL) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.', 'interventionNames': ['Drug: Triamcinolone Acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Verapamil Group', 'description': 'Patients were managed with intralesional verapamil hydrochloride (2.5 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.', 'interventionNames': ['Drug: Verapamil Hydrochloride']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Patients received intralesional triamcinolone acetonide (20 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.', 'armGroupLabels': ['Triamcinolone Group']}, {'name': 'Verapamil Hydrochloride', 'type': 'DRUG', 'description': 'Patients were managed with intralesional verapamil hydrochloride (2.5 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.', 'armGroupLabels': ['Verapamil Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bahawal Victoria Hospital/Quaid-e-Azam Medical College', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}], 'overallOfficials': [{'name': 'Bakhtawar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur'}, {'name': 'Salman Ashraf, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}