Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 2:12 AM
Study NCT ID:
NCT05629468
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2022-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy of Azithromycin and Probiotics for Treatment of 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': 'D017963', 'term': 'Azithromycin'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2022-11-09', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change or reduction in the Total Lesion Count', 'timeFrame': 'at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).', 'description': 'number of acne lesions are counted at every follow up to see whether lesions are reduced than the baseline or not'}], 'secondaryOutcomes': [{'measure': 'change or reduction in the Dermatology Life Quality Index score', 'timeFrame': 'at start of the study (baseline) and 12 weeks (last follow up visit).', 'description': "improvement in patients' quality of life was assessed to see whether the score has been reduced than the baseline score or not. it was assessed by a 10-item self assessment questionnaire i.e Dermatology Life Quality Index. the score ranges between 0 to 30. higher score means worst outcome and the lower score means better outcome."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris', 'detailedDescription': "this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \\& improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Patients of Mild and Moderate acne\n* Aged between 15 and 35 years\n\nExclusion Criteria:\n\n* Severe acne or any systemic inflammatory disease\n* Other oral treatment for acne\n* Allergic to any drug being used in the study\n* Pregnancy\n* PCOs\n* Any drug which can interact with azithromycin'}, 'identificationModule': {'nctId': 'NCT05629468', 'briefTitle': 'Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Pak Emirates Military Hospital'}, 'officialTitle': 'Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'A/28/EC/337/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin and Topical', 'description': 'group A (n=25) received tab. azithromycin 250mg oral on alternate days and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months', 'interventionNames': ['Drug: Azithromycin', 'Drug: Benzoyl Peroxide 4 % Topical Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotics and Topical', 'description': 'group B (n=25) received Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months', 'interventionNames': ['Drug: Probiotic Formula', 'Drug: Benzoyl Peroxide 4 % Topical Cream']}, {'type': 'OTHER', 'label': 'Azithromycin and Probiotics and Topical', 'description': 'combination group C (n=25) received tab. azithromycin 250mg oral on alternate days, Probiotic sachet oral once a day everyday and topical cream benzoyl peroxide 4% twice a day daily for a period of 3 months', 'interventionNames': ['Drug: Azithromycin', 'Drug: Probiotic Formula', 'Drug: Benzoyl Peroxide 4 % Topical Cream']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['"Zetro" by "Getz Pharma"'], 'description': 'antibiotic', 'armGroupLabels': ['Azithromycin and Probiotics and Topical', 'Azithromycin and Topical']}, {'name': 'Probiotic Formula', 'type': 'DRUG', 'otherNames': ['"Hi-Flora" by "Unicare Bioceuticals"'], 'description': 'probiotics', 'armGroupLabels': ['Azithromycin and Probiotics and Topical', 'Probiotics and Topical']}, {'name': 'Benzoyl Peroxide 4 % Topical Cream', 'type': 'DRUG', 'otherNames': ['"Benoxyl" by "Glitz pharma"'], 'description': 'topical cream', 'armGroupLabels': ['Azithromycin and Probiotics and Topical', 'Azithromycin and Topical', 'Probiotics and Topical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'PEMH', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Akbar W Syed, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Riphah International University, Islamabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pak Emirates Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Mushayada Irshad', 'investigatorAffiliation': 'Pak Emirates Military Hospital'}}}}