Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT05684861
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2023-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum TWEAK Levels in 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': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum level of TWEAK', 'timeFrame': '12 weeks', 'description': 'To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.'}], 'secondaryOutcomes': [{'measure': 'evaluate the effect of systemic isotretinoin on serum TWEAK level', 'timeFrame': '12 weeks', 'description': 'the comparison of the serum TWEAK before and after treatment with isotretinoin in moderate and severe cases of acne vulgaris.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'Evaluate the serum level of TWEAK in patients with AV and their relations before and after treatment with isotretinoin.', 'detailedDescription': 'Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules, and occasionally scars. Its pathogenesis includes follicular hyperkeratinization, sebaceous hypersecretion due to androgen stimulation, follicular colonization by Propionibacterium acnes, immune and inflammatory responses. It affects the face, anterior chest, and upper back . Inflammation is regarded as a key component in the pathogenesis of acne . An increase in the activity of the pro inflammatory cytokine, interleukin (IL) 1, is observed before the beginning of hyperproliferation around the uninvolved follicles and is thought to trigger the activation of keratinocyte proliferation. Nuclear factor kappa beta (NF κβ) regulated mRNA gene levels of the cytokines tumour necrosis factor (TNF) α, IL 1 β, IL 8 and IL 10 levels also affected.\n\nIsotretinoin (13-cis retinoic acid) is a synthetic analog of vitamin A. Its oral form is prescribed for severe cases which are resistant to other treatments.\n\nTumor necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) belongs to the TNF superfamily. It has an important role in the regulation of cell growth, apoptosis, angiogenesis, and immune reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases\n\nExclusion Criteria:\n\n* Pregnant and lactating women, patients with renal, GIT, skeletal, psychiatric, and endocrine disorders, sarcoidosis, and patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pill were excluded.'}, 'identificationModule': {'nctId': 'NCT05684861', 'briefTitle': 'Serum TWEAK Levels in Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin', 'orgStudyIdInfo': {'id': 'SVU MED DVA021 4 22 11 508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I patients', 'description': '90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases', 'interventionNames': ['Drug: Isotretinoin', 'Diagnostic Test: ELISA Assays of Serum TWEAK.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '60 age-sex-matched healthy subjects as a control group', 'interventionNames': ['Diagnostic Test: ELISA Assays of Serum TWEAK.']}], 'interventions': [{'name': 'Isotretinoin', 'type': 'DRUG', 'description': 'systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months', 'armGroupLabels': ['Group I patients']}, {'name': 'ELISA Assays of Serum TWEAK.', 'type': 'DIAGNOSTIC_TEST', 'description': ': From each subject, 5mL of blood was collected into vacutainers before and after treatment with isotretinoin. The blood samples were centrifuged at 3000g for 10 min at a temperature of 4°C, then . Quantitative determinations for serum TWEAK were achieved using the corresponding commercially available ELISA kit supplied by the AssayMax', 'armGroupLabels': ['Control group', 'Group I patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83522', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'South Valley University', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Hassan M Ibrahim, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'South Valley University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hassan Mohammed Ibrahim', 'investigatorAffiliation': 'South Valley University'}}}}