[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725835":3,"trial-entities:NCT07725835":96,"trial-summary:NCT07725835":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":13,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":89,"overall_officials":92,"references":94,"see_also_links":95},"NCT07725835","STUDY26010104","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","NOT_YET_RECRUITING","2028-07","2026-07","2026-07-24","University of Pittsburgh","OTHER",false,"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.",null,[18],"Skin Hydration in Healthy Volunteers",[],"INTERVENTIONAL",[22],"NA",{"count":24,"type":25},30,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DIETARY_SUPPLEMENT","Fermented Papaya Preparation (FPP)","Immun'Age Fermented Papaya Preparation",[32],"Fermented Papaya Preparation",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Transepidermal Water Loss (TEWL)","9 anatomical sites. Unit g\u002Fm²\u002Fh","From enrollment to the end of FPP at 12 weeks.",{"measure":39,"description":40,"timeFrame":37},"Skin surface pH","9 anatomical sites.",{"measure":42,"description":43,"timeFrame":37},"Skin surface temperature","9 anatomical sites. Unit Celsius",[45,48,51,54],{"measure":46,"description":47,"timeFrame":37},"Monocyte Inflammation Marker","CD16",{"measure":49,"description":50,"timeFrame":37},"Glucose Levels","Unit mg\u002FdL",{"measure":52,"description":53,"timeFrame":37},"HbA1c Levels","Percentage",{"measure":55,"description":56,"timeFrame":37},"Complete Blood Count (CBC)","Absolute Counts","ALL","50 Years","75 Years",true,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"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.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":86},"McGowan Institute for Regenerative Medicine","Pittsburgh","Pennsylvania","15219","United States",[76,81,84],{"name":77,"role":78,"phone":79,"email":80},"Savita Khanna, PhD","CONTACT","412-624-5500","savitakhanna@pitt.edu",{"name":82,"role":78,"email":83},"Scot King, DPT","scot.king@pitt.edu",{"name":77,"role":85},"PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},40.44062,-79.99589,[90,91],{"name":77,"role":78,"phone":79,"email":80},{"name":82,"role":78,"email":83},[93],{"name":77,"affiliation":12,"role":85},[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Healthy Volunteers",[],{"nct_id":4,"found":60,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional pilot study with 30 healthy volunteers. The study will test the effects of Fermented Papaya Preparation (FPP).","completed","Study of Fermented Papaya Preparation (FPP) for Skin Hydration","This study is looking at how a dietary supplement called Immun'Age Fermented Papaya Preparation (FPP) affects skin hydration in healthy volunteers. Researchers want to see if FPP can improve the skin's barrier function, especially in areas like the face, arms, and hands that might show signs of dryness. They will measure this by looking at Transepidermal Water Loss (TEWL), which indicates how much water your skin loses. You may be able to join if you are between 50 and 75 years old and are generally healthy. The study will measure TEWL, skin surface pH, and skin surface temperature over 12 weeks to see if FPP has a positive effect. The current status of this study is unclear.","Participants will be followed for 8 weeks after the 12-week treatment period, for a total of 20 weeks.",117,"You would attend 5 visits over 20 weeks. This includes 12 weeks of taking FPP daily and logging your intake, and allowing 3 blood samples to be collected.","Not stated in the trial record.",[29],"v2"]