protocolSection identificationModule nctId: NCT06301997, orgStudyIdInfo id: IRCT20210218050404N5, secondaryIdInfos id: IR.FUMS.REC.1400.125, type: OTHER, domain: Fasaums, briefTitle: A Herbal Compound for Psoriasis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fasa University of Medical Sciences, class: OTHER, collaborators name: Zarrin Avaye Kowsar Salamat (ZAX company), descriptionModule briefSummary: The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks., conditionsModule conditions: Psoriasis, conditions: Inflammation, conditions: Skin Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ACTUAL, armsInterventionsModule interventions name: ZAX.1400.P03, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, secondaryOutcomes measure: Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fasa university of medical sciences, city: Fasa, state: Fars, zip: 7461686688, country: Iran, Islamic Republic of, geoPoint lat: 28.9383, lon: 53.6482, hasResults: False