[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07221773":3,"trial-entities:NCT07221773":101,"trial-summary:NCT07221773":105},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":49,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":72,"locations":75,"central_contacts":93,"overall_officials":94,"references":99,"see_also_links":100},"NCT07221773","XVIEP-2025-001","Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair","Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair","ENROLLING_BY_INVITATION","2027-02","2025-11","2026-06-08","2025-09-29","Restore Biologics Holdings, Inc. dba Xtressé","INDUSTRY",false,"The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair.\n\nThe main aims of this trial are:\n\n1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.\n2. To gauge patient satisfaction with hair changes and application process.\n\nParticipants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.","XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.\n\nIn the study, participants will be asked to complete the following:\n\n* Provide basic personal Information\n* Provide a Medical \\& Surgical History\n* Follow study requirements to avoid certain medication and treatments\n* Complete all study visits and follow-up calls\n* Complete self-assessments and treatment use logs\n* Allow clinical assessment and photographic documentation of treatment.\n\nAll participants have the right to refuse further participation in the study at any time.",[19],"Hair Thinning",[21,22,23,24,25],"hair loss","hair thinning","Alopecia","thin hair","thinning hair","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},15,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"OTHER","XVIE","Acellular Allogenic Human Amniotic Fluid (hAF)",[39],"XVIE microneedling process applied to the scalp twice over a 4 month period.",[41,45],{"measure":42,"description":43,"timeFrame":44},"Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis","Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE","From enrollment to the end of treatment at 4 months",{"measure":46,"description":47,"timeFrame":48},"Incidence of Adverse Events associated with Treatment","Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.","From first treatment until the end of treatment at 4 months.",[50],{"measure":51,"description":52,"timeFrame":53},"Hair Density Changes measured by SOCAi","Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.","From enrollment to the end of the study at 4 months","FEMALE","28 Years","65 Years",{"inclusion":58,"exclusion":64,"raw_text":71},[59,60,61,62,63],"Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).","Ludwig Scale 1 to 2","Fitzpatrick skin types I to VI.","Ability and willingness to comply with the study protocol.","Commitment to using effective contraception throughout the study if of childbearing potential.",[65,66,67,68,69,70],"Pregnancy, nursing, or recent initiation of hormone therapy.","Change in other hair treatments within 3 months prior to the study.","Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).","History of hair or scalp disorders that could interfere with study results.","History of keloid formation or poor wound healing","History of bleeding and\u002For clotting disorders","Inclusion Criteria:\n\n* Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).\n* Ludwig Scale 1 to 2\n* Fitzpatrick skin types I to VI.\n* Ability and willingness to comply with the study protocol.\n* Commitment to using effective contraception throughout the study if of childbearing potential.\n\nExclusion Criteria:\n\n* Pregnancy, nursing, or recent initiation of hormone therapy.\n* Change in other hair treatments within 3 months prior to the study.\n* Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).\n* History of hair or scalp disorders that could interfere with study results.\n* History of keloid formation or poor wound healing\n* History of bleeding and\u002For clotting disorders",[73,74],"ADULT","OLDER_ADULT",[76,85],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Advanced Dermatology & Cosmetic Surgery","Maitland","Florida","32751","United States",{"lat":83,"lon":84},28.62778,-81.36312,{"facility":86,"city":87,"state":88,"zip":89,"country":81,"geoPoint":90},"Kindred Hair & Skin Center","Marriottsville","Maryland","21104",{"lat":91,"lon":92},39.3501,-76.89942,[],[95],{"name":96,"affiliation":97,"role":98},"Melissa Y Rayner, MS","Restore Biologics Holding, Inc dba Xtressé","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[23,103],"Female Pattern Hair Loss",[],{"nct_id":4,"found":15,"summary":106,"prompt_version":106},null]