Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:14 AM
Study NCT ID:
NCT07461103
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Topical Insulin on Healing Rate of Pemphigus Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010392', 'term': 'Pemphigus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three-arm, parallel-group, randomized controlled trial Within-patient comparison design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Healing', 'timeFrame': 'Up to 14 days', 'description': 'Number of days required for complete epithelialization of the lesion'}], 'secondaryOutcomes': [{'measure': 'Lesion Surface Area Reduction', 'timeFrame': 'Baseline, Day 7, Day 14', 'description': 'Percentage reduction in lesion surface area from baseline,Measured using ImageJ software from standardized photographs'}, {'measure': 'Daily Healing Rate', 'timeFrame': '14 days', 'description': 'Percentage of healing per day,Calculated as percentage of surface area reduction per day'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pemphigus vulgaris', 'topical insulin', 'wound healing', 'Insulin Glargine', 'Regular Insulin', 'Autoimmune Blistering Disease', 'Erosions'], 'conditions': ['Pemphigus Vulgaris', 'Skin Erosion', 'Autoimmune Blistering Disease']}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy of topical insulin in promoting healing of pemphigus vulgaris erosions. Twenty patients with pemphigus vulgaris were enrolled, each contributing three comparable lesions randomly allocated to receive long-acting insulin (insulin glargine), short-acting insulin (regular insulin), or normal saline control. Treatments were applied topically twice daily for 14 days or until complete healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of pemphigus vulgaris by clinical and histopathological criteria\n* Presence of erosions and/or ulcers on skin and/or mucous membranes\n* At least three lesions of comparable location, size, depth, and healing stage\n\nExclusion Criteria:\n\n* Lesions with clinical signs of secondary infection (purulence, surrounding erythema, fever)\n* Uncontrolled general condition significantly affecting wound healing (e.g., hypoalbuminemia)\n* Known allergy to insulin'}, 'identificationModule': {'nctId': 'NCT07461103', 'briefTitle': 'Effect of Topical Insulin on Healing Rate of Pemphigus Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Topical Insulin on Healing Rate of Pemphigus Lesions', 'orgStudyIdInfo': {'id': '0108172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-acting insulin (LA)', 'description': 'Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily', 'interventionNames': ['Drug: insulin glargine']}, {'type': 'EXPERIMENTAL', 'label': 'Regular human insulin (SA)', 'description': 'Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily', 'interventionNames': ['Drug: human insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily', 'interventionNames': ['Drug: 0.9% Normal Saline']}], 'interventions': [{'name': 'insulin glargine', 'type': 'DRUG', 'otherNames': ['lantus'], 'description': 'Topical application of insulin glargine (100 IU/mL) at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing', 'armGroupLabels': ['Long-acting insulin (LA)']}, {'name': 'human insulin', 'type': 'DRUG', 'otherNames': ['actrapid'], 'description': 'topical application of regular insulin (100 IU/mL) at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing', 'armGroupLabels': ['Regular human insulin (SA)']}, {'name': '0.9% Normal Saline', 'type': 'DRUG', 'otherNames': ['control, placebo'], 'description': 'Topical application of 0.9% normal saline at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22301', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria main university hospital, Department of Dermatology and Venereology', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Tarek M Hussein, MB BCh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}, {'name': 'Carmen I Farid, MB BCh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}