Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 3:08 PM
Study NCT ID:
NCT05926869
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris
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': 'D002981', 'term': 'Clindamycin'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-06-23', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris', 'timeFrame': 'It will be assessed upto 03 months', 'description': 'Efficacy will be assessed using Global Acne Grading Sore ( GAGS ). For GAGS (Score 1-18 = mild, score 19-30 = moderate, score 31-38 = severe). Mean difference of GAGs score before and after the treatment will be calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'Acne vulgaris (AV) is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. The key pathogenic processes includes alteration of follicular keratinization that leads to comedones; increased and altered sebum production under androgen control; follicular colonization by Propionibacterium acnes; . The role of topical antibiotics in treating acne is well established. Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. The extensive use of antibiotics in acne has lead to the development of resistance to antimicrobial therapy. Dapsone is known to have antibacterial as well as anti-inflammatory action which may help in reduction of acne.', 'detailedDescription': 'Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate acne vulgaris\n* either gender\n* 20 to 50 yrs\n\nExclusion Criteria:\n\n* systemic treatment taken\n* pregnant or lactating women\n* hematological abnormalities'}, 'identificationModule': {'nctId': 'NCT05926869', 'briefTitle': 'Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jinnah Postgraduate Medical Centre'}, 'officialTitle': 'Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris', 'orgStudyIdInfo': {'id': 'NO.F.2-81/2022-GENL/250/JPMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A Clindamycin gel', 'interventionNames': ['Drug: Clindamycin and Dapsone gel for 03 months']}, {'type': 'EXPERIMENTAL', 'label': 'Group B Dapsone gel', 'interventionNames': ['Drug: Clindamycin and Dapsone gel for 03 months']}], 'interventions': [{'name': 'Clindamycin and Dapsone gel for 03 months', 'type': 'DRUG', 'description': 'Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris. It has antibacterial as well as anti inflammatory effects', 'armGroupLabels': ['Group A Clindamycin gel', 'Group B Dapsone gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'JPMC', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'khadija Asadullah, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jpmc'}, {'name': 'Faiza Inam, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jpmc'}, {'name': 'Nazia Jabeen, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JPMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinnah Postgraduate Medical Centre', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Parisa Sanawar', 'investigatorAffiliation': 'Jinnah Postgraduate Medical Centre'}}}}