Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT07113756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Topical Treatment in Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-02', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical improvement in psoriatic skin lesions', 'timeFrame': 'at the end of treatment (12 weeks) and 3 months after stoppage of treatment', 'description': 'clinical evaluation using PASI score to assess improvement before and treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'Psoriasis is a chronic, recurring, immune-mediated papulosquamous condition The etiology of psoriasis is complex and not fully understood Though many treatment options are available for plaque psoriasis, each has its limitations and side effects. Therefore, the need for an effective topical agent that delivers the drug efficiently into the target site with minimal systemic side effects remains an aim in itself.Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. In addition to its hypoglycaemic effect, metformin can serve as an anti-inflammatory agent. Metformin has been demonstrated to suppress proliferation in keratinocytes by blocking the mitogen-activated protein kinase pathway (MAPK) (25). Hence, metformin may play an important role in the reducing pathogenesis of psoriasis by anti-inflammatory, anti-proliferative, and anti- angiogenic effects .The topical form of metformin has been used in regenerative medicine (33), treatment of acne (34), adjuvant treatment for psoriasis (35), neo-adjuvant therapy for squamous cell carcinoma (36), and treatment of pigmentary disorders as an alternative to hydroquinone (37). The aim of the study is to:\n\n* Assess the efficacy and the safety of topical metformin 30% cream compared with betamethasone valerate 0.1 % cream in the treatment of adult patients with mild and moderate plaque psoriasis.\n* Compare the efficacy of topical metformin 30% cream versus betamethasone valerate 0.1 % cream clinically, dermoscopically, histopathologically and immunohistochemically by measuring tissue level of IL17 in psoriatic skin lesions before and after treatment in all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Patients of both sexes aged ≥ 18 years, having clinical and dermoscopic finding of mild and moderate plaque psoriasis and did not receive any topical, phototherapy or systemic treatment in the last 3 months for psoriasis.\n* Exclusion Criteria:\n\n * Other types of psoriasis\n * Patient refusal.\n * Pregnant and lactating women.\n * Patients with other inflammatory or autoimmune skin diseases (atopic dermatitis, lichen planus, alopecia areata, cutaneous lupus erythromatosis, systemic sclerosis, rheumatoid arthritis, acne vulgaris, hidradinitis supprativa\n * Hypersensitivity to topical treatment.'}, 'identificationModule': {'nctId': 'NCT07113756', 'briefTitle': 'New Topical Treatment in Plaque Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy of Topical Metformin 30% Cream Versus Betamethasone Valerate 0.1% Cream in Treatment of Adult Patients With Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'Soh-Med-25-2-2MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group (1) will use topical metformin 30% cream', 'description': 'each patient will use topical metformin 30% cream twice daily for 12 weeks.\n\no Preparation of metformin 30% cream: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. Using digital balance then Grinding the powder by pestle \\& Morter then Adding 30 ml propylene glycol and alcohol to reach a total 100 gm weight then adding parabens mix as preservative with 0.5 gm then mix thoroughly followed by Levegating \\& mixing then divide to smaller well tighten closure with labels', 'interventionNames': ['Drug: topical metformin 30% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group(2) topical betamethasone valerate .1% cream.', 'description': 'each patient will use topical betamethasone valerate .1% cream twice daily for 12 weeks.', 'interventionNames': ['Drug: betamethasone valerate.1% cream']}], 'interventions': [{'name': 'topical metformin 30% cream', 'type': 'DRUG', 'description': 'each patient will use topical metformin 30% cream twice daily for 12 weeks.\n\no Preparation of metformin 30% cream: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. Using digital balance then Grinding the powder by pestle \\& Morter then Adding 30 ml propylene glycol and alcohol to reach a total 100 gm weight then adding parabens mix as preservative with 0.5 gm then mix thoroughly followed by Levegating \\& mixing then divide to smaller well tighten closure with labels', 'armGroupLabels': ['group (1) will use topical metformin 30% cream']}, {'name': 'betamethasone valerate.1% cream', 'type': 'DRUG', 'description': 'each patient (age, sex and BMI matched) will use topical betamethasone valerate 0.1% cream twice daily for 12 weeks.\n\no Manufactured by Egyptian international pharmaceutical industries co. E.I.P.I.C.O. and will be purchased from local pharmacy, Sohag, Egypt.', 'armGroupLabels': ['group(2) topical betamethasone valerate .1% cream.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'shereen G AbdEllah, assistant lecturer', 'role': 'CONTACT', 'email': 'shereengamal157@yahoo.com', 'phone': '01033835302'}], 'overallOfficials': [{'name': 'shereen G gamal, Assistant lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will not be shared due to patient privacy concerns and lack of consent for external sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of dermatology', 'investigatorFullName': 'Sherein Gamal Abdellah', 'investigatorAffiliation': 'Sohag University'}}}}