Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT06252194
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Acne Grading System (GAGS) Score', 'timeFrame': '12 weeks', 'description': 'Acne Vulgaris Severity assesment by GAGS score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.\n\nPatients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.\n\nResearcher will compare the clinical improvement in two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed moderate and severe AV patients diagnosed by a dermatologist\n\n\\-\n\nExclusion Criteria:\n\n* Patients receiving topical retinoids within last two months\n* Pregnancy and lactation\n* History of corticosteroids intake\n* Suffering from malignancy or any cosmetic induced acne'}, 'identificationModule': {'nctId': 'NCT06252194', 'briefTitle': 'Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Comparative Study of Metformin Versus Doxycycline in Treatment of Moderate to Severe Adult Acne Vulgaris Patients: Multicentre, Randomized, Double-blind Trial.', 'orgStudyIdInfo': {'id': 'BSMMU/2022/11379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Metformin 500 mg twice daily along with topical retinoids for 12 weeks', 'interventionNames': ['Drug: Metformin and doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Doxycycline 100 mg twice daily along with topical retinoids for 12 weeks', 'interventionNames': ['Drug: Metformin and doxycycline']}], 'interventions': [{'name': 'Metformin and doxycycline', 'type': 'DRUG', 'description': 'Metformin 500 mg tablet twice daily', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'registrar', 'role': 'CONTACT', 'email': 'registrar@bsmmu.edu.bd', 'phone': '8512550'}], 'facility': 'BSMMU', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Muhammad Marnush, MBBS', 'role': 'CONTACT', 'email': 'marnushm@gmail.com', 'phone': '88001714558447'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Muhammad Marnush', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}