[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531720":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":29,"responsibleParty":44,"collaborators":29,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":29,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":29,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":29,"overallStatus":67,"whyStopped":29,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":29},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Botox group","EXPERIMENTAL","Patients will receive a single intradermal injection of Mesobotox as a monotherapy.\n\nBotulinum toxin injection: Botox injections will be intradermal. Concentration will be 100 U to be diluted with 5-ml sterile physiological sodium chloride solution. Each patient will receive individual injections of 1 U using a grid with points set at a distance of 1 cm apart. Up to two plaques per patient will be selected, whose diameter would not exceed 5-10 cm2. Each patient will receive a single BoNT-A injection",[13],"Drug: Botulinum Toxin-A",{"label":15,"type":10,"description":16,"interventionNames":17},"Botox and Tacrolimus group","Patients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Tacrolimus 0.03% ointment twice daily for 3 months.",[13,18],"Drug: Tacrolimus",{"label":20,"type":10,"description":21,"interventionNames":22},"Tacrolimus group","Patients will apply Tacrolimus (0.03%) as a monotherapeutic twice daily for 3 months",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Botulinum Toxin-A","Botulinum Toxin-A (BoNT-A) is an injectable neuromodulator produced by Clostridium Botulinum, a Gram-positive bacillus that causes Botulism.",[15,9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Tacrolimus","topical Calcineurin inhibitor",[15,20],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Amira Ali, MD","CONTACT","0201005263721","amiraali21@yahoo.com",{"name":41,"role":37,"phone":42,"phoneExt":29,"email":43},"Ayman Mahran, MD","02012231210000","aymanderma@yahoo.com",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","SNIsrael","principal investigator","100531720","phase-4-botox-versus-tacrolimus-in-psoriasis-vulgaris-100531720",false,"NCT06203470","Botox Versus Tacrolimus in Psoriasis Vulgaris","Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison\u002FCombination With Topical Calcineurin Inhibitor","Inclusion Criteria:\n\n* Patients with clinical diagnosis of mild to moderate psoriasis vulgaris\n* Patients who stopped any systemic therapy or phototherapy for at least 3 months and topical therapy for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* • Psoriasis vulgaris involving \\> 10% of the body surface area, pustular or erythrodermic psoriasis.\n\n  * Patients with neuromuscular disease or history of epilepsy.\n  * Pregnant or lactating females.\n  * Patients with any current dermatological disease.\n  * Patients with any current systemic disease.","ALL","18 Years","60 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","Psoriasis is a systemic chronic relapsing immune-mediated disease which often requires a long-term therapy. Psoriasis occurs in around 2-3% of the total global population. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3%.\n\nBesides, it could have profound implications on the patients' psychological state and quality of life.\n\nIt is presented by erythematous, scaly plaques over the preferred sites. The pathogenesis of this highly complex disease is still far from being fully understood. Keratinocytes' hyperproliferation and immune system dysfunctions are well recognized contributors, with numerous treatments targeting these unique immunologic dysfunctions.",[66],"Psoriasis Vulgaris","NOT_YET_RECRUITING","2024-06-11",{"date":70,"type":71},"2024-06-12","ACTUAL",{"date":73,"type":60},"2024-06",{"date":75,"type":60},"2026-10",{"name":5,"class":6}]