[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599305":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":41,"responsibleParty":62,"collaborators":21,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":21,"enrollmentInfo":74,"targetDuration":21,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":21,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Tarian Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intra-individual active comparator vs no intervention","EXPERIMENTAL","Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control",[13,14],"Drug: Brimonidine gel","Other: No intervantion",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Brimonidine gel","TAR-0520 gel",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"OTHER","No intervantion","No treatment",[9],[28],{"name":29,"affiliation":5,"role":30},"Janusz M Czernielewski, MD, PhD","STUDY_DIRECTOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Janusz M Czernielewski, MD","CONTACT","+33680338274","janusz.czernielewski@tarianpharma.com",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Alexandra MS Lamquin, PharmD","+33623363962","alexandra.lamquin@tarianpharma.com",[42],{"facility":43,"status":21,"city":44,"state":21,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Institut Paoli-Calmettes","Marseille","13009","France","FR",{"type":49,"coordinates":50},"Point",[51,52],5.38107,43.29695,{"lat":52,"lon":51},[55,59],{"name":56,"role":34,"phone":57,"phoneExt":21,"email":58},"Alexandre Tassin de Nonneville, MD","+33491223333","denonnevillea@ipc.unicancer.fr",{"name":60,"role":61,"phone":21,"phoneExt":21,"email":21},"Alexandre Tassin de Nonneville, MD,PhD","PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100599305","phase-2-safety-and-efficacy-study-of-tar-0520-gel-in-prevention-of-taxane-induced-peripheral-neuropathy-100599305",false,"NCT07082764","Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy","A Phase 2a Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy","TARIAN 014","Inclusion Criteria:\n\n* Male or female, who is at least 18 years of age or older\n* Patients with clinical diagnosis of breast cancer\n* Patients planned to be treated with paclitaxel or docetaxel\n* Patients who can understand and sign the Informed Consent Form\n* Patients who can apply the study gel by himself \u002Fherself or has a giver that can apply the product.\n* Female patients of childbearing potential who agree to use a highly effective method of contraception throughout the study\n\nExclusion Criteria:\n\n* Patient already treated with taxanes or other chemotherapies known to induce neuropathies\n* Patient with previously diagnosed peripheral neuropathy\n* Patient with concomitant therapies known to induce neuropathies\n* Patient treated for neuropathic pain\n* Patient with comorbid factors known to induce neuropathies (such as Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies)\n* Patient currently receiving monoamine oxidase (MAO) inhibitors therapy or patients on antidepressants which affect noradrenergic transmission e.g. tricyclic antidepressants and mianserin (as mentioned in the current topical brimonidine labeling of approved products).\n* Patient who will not be able to follow the protocol for physical or psychological reasons\n* Patient with history of skin disorders, significant skin disease, irritated skin or open wounds within the same body areas planned for the IMP application.\n* Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure\u002FProduct label)\n* Female who is pregnant or lactating\n* Female who intends to conceive a child during the clinical trial","ALL","18 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures.\n\nThis study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity.\n\nBreast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control.\n\nPatients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.",[82],"Chemotherapy Induced Peripheral Neuropathy",[84,85],"taxane-induced peripheral neuropathy","taxane-induced nail toxicities","NOT_YET_RECRUITING","2025-07-16",{"date":89,"type":90},"2025-07-24","ACTUAL",{"date":92,"type":76},"2025-09-01",{"date":94,"type":76},"2026-12-15",{"name":5,"class":6},1]