[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488727":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Palvella Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PTX-022","EXPERIMENTAL",null,[13],"Drug: PTX-022",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","QTORIN rapamycin 3.9% anhydrous gel",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Emily Cook","CONTACT","267-738-6366","emily.cook@palvellatx.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Minnesota Clinical Study Center","RECRUITING","New Brighton","Minnesota","55112","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-93.20189,45.06552,{"lat":38,"lon":37},[41,44],{"name":42,"role":22,"phone":43,"phoneExt":11,"email":11},"Study Coordinator","763-502-2929",{"name":45,"role":46,"phone":11,"phoneExt":11,"email":11},"Steven E Kempers, MD, FAAD","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100488727","phase-3-a-study-evaluating-the-safety-and-pharmacokinetics-of-qtorin-rapamycin-39-anhydrous-gel-in-the-treatment-of-adults-with-pachyonychia-congenita-100488727",false,"NCT05643872","A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita","A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita","Key Inclusion Criteria:\n\n* Completed the PALV-05 (VAPAUS) study\n* Agree to contraceptive use\n\nKey Exclusion Criteria:\n\n* Females who are pregnant or breastfeeding\n* Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical)\n* Any significant concurrent condition that could adversely affect participation and\u002For the assessment of the safety and efficacy in the study\n* Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and\u002For the assessment of the safety and efficacy in the study","ALL","16 Years",{"count":59,"type":60},45,"ESTIMATED","INTERVENTIONAL",[63],"PHASE3","PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial.\n\nThe purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or \"PTX-022\".",[66],"Pachyonychia Congenita","2022-12-01",{"date":69,"type":70},"2022-12-09","ACTUAL",{"date":72,"type":70},"2022-11-15",{"date":74,"type":60},"2023-11",{"name":5,"class":6},1]