Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:56 AM
Study NCT ID:
NCT07384793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Acne Lesion Count as per Acne Global assessment scale', 'timeFrame': '12 Weeks', 'description': 'The patients will be assessed before and after the treatment and their lesions will be counted .The Primary outcome that will be measured is the reduction of the lesion counts according to the Acne global Assessment scale\n\nThe participants included will be with mild to moderate acne on basis of global acne assessment scale score of 2 or 3.\n\nThe minimum Lesion count considered will be 20 and the Maximum will be 50.\n\nLower is better Higher is worse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris II or III Degree']}, 'descriptionModule': {'briefSummary': 'The Goal of this Clinical trial is to compare the efficacy of oral azithromycin alone with combination therapy of oral azithromycin and probiotics to see is there any significant difference in outcome of two treatment modalities in mild to moderate acne vulgaris'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Participants with mild to moderate acne on basis of global acne assessment scale score of 2 or 3 and with 20 to 50 total lesion count will be included.\n\n\\-\n\nExclusion Criteria:\n\nHistory of active localized or generalized infection History of autoimmune disease History of other facial skin diseases/ excessive facial hair or scars History of using isotretinoin or oral contraceptive pills in past 6 months History of already using antibiotics for acne treatment History of facial cosmetic procedures within last 3 months History of allergy to drugs used in study History of using drugs that may interact with azithromycin Currently pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT07384793', 'briefTitle': 'Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayatabad Medical Complex'}, 'officialTitle': 'Comparison of Efficacy of Azithromycin Alone vs Combination of Azithromycin and Probiotics in Management of Mild to Moderate Acne Vulgaris', 'orgStudyIdInfo': {'id': 'HMC Peshawar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Azithromycin group', 'description': 'The participants in this arm of study will receive only Oral Azithromycin to treat their Acne', 'interventionNames': ['Drug: Azithromycin 250 MG Oral Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Azithromycin and Oral probiotic combination', 'description': 'The participants in this arm of study will receive both Oral Azithromycin and Oral Probiotics to treat their Acne', 'interventionNames': ['Drug: Azithromycin 250 MG Oral Capsule Along with Oral Probiotics']}], 'interventions': [{'name': 'Azithromycin 250 MG Oral Capsule', 'type': 'DRUG', 'description': 'The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day for 12 weeks to treat their Acne', 'armGroupLabels': ['Oral Azithromycin group']}, {'name': 'Azithromycin 250 MG Oral Capsule Along with Oral Probiotics', 'type': 'DRUG', 'description': 'The participants in this arm of study will receive only Oral Azithromycin 250mg on alternate day along with oral probiotics daily for 12 weeks to treat their Acne', 'armGroupLabels': ['Oral Azithromycin and Oral probiotic combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peshawar', 'country': 'Pakistan', 'facility': 'Hayatabad Medical Complex', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Ayesha Naeem', 'role': 'STUDY_CHAIR', 'affiliation': 'Hayatabad Medical Complex Peshawar, KPK Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayatabad Medical Complex', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dermatology unit HMC', 'investigatorFullName': 'Naheed asghar', 'investigatorAffiliation': 'Hayatabad Medical Complex'}}}}