[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648808":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":20,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fermented Papaya Preparation","EXPERIMENTAL","Fermented Papaya Preparation Supplement",[13],"Dietary Supplement: Fermented Papaya Preparation (FPP)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Fermented Papaya Preparation (FPP)","Immun'Age Fermented Papaya Preparation",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Savita Khanna, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","412-624-5500","savitakhanna@pitt.edu",{"name":31,"role":27,"phone":20,"phoneExt":20,"email":32},"Scot King, DPT","scot.king@pitt.edu",[34],{"facility":35,"status":20,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"McGowan Institute for Regenerative Medicine","Pittsburgh","Pennsylvania","15219","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-79.99589,40.44062,{"lat":45,"lon":44},[48,49,50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":31,"role":27,"phone":20,"phoneExt":20,"email":32},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Savita Khanna","Professor",[55],{"name":56,"class":6},"Osato Research Institute","100648808","effect-of-fpp-on-cutaneous-barrier-integrity-100648808",false,"NCT07725835","Effect of FPP on Cutaneous Barrier Integrity","Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands","FPP OSATO","Inclusion Criteria:\n\n1. 50-75 years\n2. Willing to allow collection of 3 blood samples (Baseline, Week 12 and Week 20)\n3. Willing to log daily compliance with FPP intake during the study period (12 weeks)\n4. Absence of active systemic disease per investigator judgement.\n5. No current use of immunosuppressant or immunomodulatory medications.\n6. No active dermatological conditions at measurement sites that could impair measure, per investigator judgement.\n7. Investigator determination of general good health.\n\nExclusion Criteria:\n\n1. Co-morbidity or concurrent medication that the Investigator deems impactful to patient safety or ability to adhere to FPP dosage.\n2. Co-morbidity or concurrent medication that the Investigator deems confounding to outcome measure (i.e., topical or systemic steroid).\n3. Current or history of allergy to FPP ingredients: Dextrose, Carica papaya, or Food yeast.\n4. Concurrent participation in another interventional trial that may impact measures, per investigator judgement.\n5. Uncontrolled diabetes (A1c \\>7%).\n6. Open wounds or actively receiving Wound Care services.\n7. Pregnant or breastfeeding women.\n8. Current use of warfarin.",true,"ALL","50 Years","75 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","This pilot study will test how Fermented Papaya Preparation (FPP) impacts overall TEWL of areas that commonly display diminished barrier function, such as the skin from face, arms, and hands. Areas of diminished barrier function are defined as those not visible to the eye but identified as areas of high transepidermal water loss (TEWL) as measured by a non-invasive pen-like device. A TEWL value of 20 or higher at a location would be considered high TEWL. Participants will attend 5 visits over 20 weeks, with 12-weeks of FPP treatment, and 8-weeks of follow-up.",[77,78],"Skin Barrier Dysfunction","Healthy Volunteers","NOT_YET_RECRUITING","2026-08-17",{"date":82,"type":83},"2026-08-19","ACTUAL",{"date":85,"type":71},"2026-09",{"date":87,"type":71},"2028-07",{"name":5,"class":6},1]