[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-plaque-psoriasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-plaque-psoriasis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100648825","phase-4-an-open-label-trial-to-evaluate-efficacy-and-safety-of-roflumilast-03-cream-for-chronic-plaque-and-nail-psoriasis-100648825",false,"NCT07725822","An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis","Inclusion Criteria:\n\n1. Participants legally competent to sign and give informed consent.\n2. Males and females ages 12 years of age and older.\n3. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable psoriasis for the past 6 months and stable nail disease for the past 6 months.\n4. Psoriasis vulgaris on the face, extremities, trunk, and\u002For intertriginous areas and groin (excluding the scalp, palms and soles).\n5. Nail psoriasis affecting ≥3 fingernails on hands.\n6. An Investigator's Global Assessment of disease severity (IGA) or (I-IGA) of at least Almost Clear ('1') at Baseline\n7. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) (if not combined).\n\n   * In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.\n   * Highly effective forms of contraception include: oral\u002Fimplant\u002Finjectable\u002Ftransdermal contraceptives, intrauterine device, and partner's vasectomy.\n   * If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required.\n   * The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.\n8. In good health as judged by the Investigator, based on medical history, physical examination.\n\nExclusion Criteria:\n\n1. Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).\n2. Subjects who currently have or plan to have gel or acrylic overlays on nails during the study.\n3. Subjects who cannot discontinue nail care habits that will confound efficacy and safety assessments (e.g. buffing, filing, excessive trimming). Routine simple clipping is allowed.\n4. Subjects who cannot discontinue any nail topcoat products (e.g. hardeners, strengtheners, nail polish) Simple nail polish will be allowed for special events and removed the next day. Subject will note in diary days this occurs and the total days may not exceed 5 study days.\n5. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.\n6. Subjects currently taking lithium or antimalarial drugs.\n7. Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).\n8. Current diagnosis of drug-induced psoriasis.\n9. Any recent infection, presence of onychomycosis or any other confounding nail disorder as determined by investigator.\n10. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.\n11. Known allergies to excipients in roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphate and ceteth-10 phosphate).\n12. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.\n13. Previous treatment with any topical PDE4i. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 6 months.\n14. Known or suspected:\n\n    * severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C)\n    * known HIV infection\n    * hypersensitivity to component(s) of the study drugs\n    * history of severe depression, suicidal ideation\n15. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.\n16. Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.\n17. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.\n18. Subjects who are family members of the clinical study site, clinical study staff \u002F sponsor, or family members of enrolled subjects.\n19. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.\n20. History of and\u002For concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE-4 inhibitors.\n21. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.","ALL",{"count":17,"type":18},15,"ESTIMATED","INTERVENTIONAL",[21],"PHASE4","This is an open label trial in subjects ≥12 years of age and older with chronic plaque psoriasis and moderate to severe nail psoriasis.\n\nEligible participants will apply roflumilast 0.3% cream daily for 24 weeks to affected nails daily for the entire study duration and to psoriasis plaques daily until clear.",[24,25],"Chronic Plaque Psoriasis","Nail Psoriasis",[24,25],"NOT_YET_RECRUITING","2026-07-24",{"date":30,"type":31},"2026-07-28","ACTUAL",{"date":33,"type":18},"2026-08",{"date":35,"type":18},"2027-08",{"name":37,"class":38},"Modern Research Associates, PLLC","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":19,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100637755","comparison-of-methotrexate-and-tofacitinib-in-chronic-plaque-psoriasis-100637755","NCT07581418","Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis","Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of Chronic Plaque Psoriasis","Inclusion Criteria:\n\n* Eligible participants will comprise adults aged 18 to 70 years, of either gender, with moderate to severe plaque psoriasis defined by a Psoriasis Area and Severity Index (PASI) score greater than 10. A minimum disease duration of 6 months will be required. In addition, enrolment will be limited to patients whose psoriasis has shown inadequate response to at least one topical therapy despite a treatment duration of at least 4 weeks\n\nExclusion Criteria:\n\n* Participants with non-plaque variants of psoriasis or any other clinically significant dermatological condition that could confound the assessment of psoriasis severity. Recent exposure to anti psoriatic therapy including systemic or biologic treatment within the preceding 4 weeks or topical treatment within the preceding 2 weeks. Individuals with known hypersensitivity to, or contraindications for, either methotrexate or tofacitinib. Patients with a history of significant hepatic, renal, hematologic, gastrointestinal, or immune system disorders. Pregnant or breastfeeding women. Patients unavoidable prolonged sun or ultraviolet exposure. Patients with a history of alcohol abuse, or other conditions that contraindicate methotrexate use..","18 Years","70 Years",{"count":50,"type":18},88,[52],"NA","This randomized controlled trial aims to compare the efficacy and safety of oral methotrexate and tofacitinib in patients with chronic plaque psoriasis. Participants diagnosed with chronic plaque psoriasis will be randomly assigned to receive either methotrexate or tofacitinib and will be followed for six months. Clinical improvement, disease severity, treatment response, and adverse effects will be assessed and compared between the two treatment groups.",[24],[56,24,57,58,59,60],"Psoriasis","Methotrexate","Tofacitinib","Randomized Controlled Trial","Systemic Therapy","2026-05-06",{"date":63,"type":31},"2026-05-12",{"date":65,"type":18},"2026-06-01",{"date":67,"type":18},"2026-12-01",{"name":69,"class":38},"Pak Emirates Military Hospital",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":15,"minAge":47,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":19,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":39},"100618885","early-phase-1-to-check-comparison-of-apremilast-and-methotrexate-efficacy-in-patients-with-moderate-to-severe-plaque-psoriasis-presented-to-tertiary-care-hospital-100618885","NCT07337434","To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital","Comparison of Efficacy of Methotrexate vs Apremilast in Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\nPatients having age between 18-60 years of either gender Diagnosed with moderate to severe plaque psoriasis (PASI ≥10) No prior systemic therapy in past 3 months.\n\nExclusion Criteria:\n\nPregnancy or lactation History of liver or renal dysfunction Known hypersensitivity to study drugs",true,"60 Years",{"count":80,"type":18},106,[82],"EARLY_PHASE1","This study aims to compare efficacy of methotrexate vs apremilast in the management of chronic plaque psoriasis.Given the high prevalence of psoriasis in Pakistan and the significant psychological impact on patients, particularly in Peshawer,this study will provide valuable insights into optimal treatment strategies.",[24],"RECRUITING","2026-01-07",{"date":88,"type":31},"2026-01-13",{"date":90,"type":18},"2025-12-25",{"date":92,"type":18},"2026-06-25",{"name":94,"class":95},"Syeda Sana Zaman","OTHER_GOV"]