[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07637071":3,"trial-entities:NCT07637071":113,"trial-summary:NCT07637071":117},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":48,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":68,"locations":71,"central_contacts":102,"overall_officials":107,"references":111,"see_also_links":112},"NCT07637071","XTSM-2026-001","Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia","Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia","NOT_YET_RECRUITING","2027-03","2026-06","2026-06-10","2026-06-22","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 an active gummy treatment in men with androgenic alopecia.\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.\n3. Monitor and report any adverse events associated with the daily intake of Xtressé\n\nParticipants who qualify will complete 3 visits after voluntary consent has been given. Participants will be given a 90-day supply of the gummies at visits 1 and 2 to cover the 6-month study period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.","In the study, participants will be asked to complete the following:\n\nProvide basic personal information (including date of birth, gender, race and ethnicity) Provide their medical\u002F surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take gummy treatment daily and complete a treatment diary Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects\n\nTo qualify for this trial, participants must:\n\nBe a male adult between 18 to 65 years of age Have hair loss in vertex region. Give voluntary written consent Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas Allow photographs of the front and top area of the scalp Confirm they are not sensitive to any of the study treatment ingredients\n\nAll photographs of the treatment area collected during the study will be used as study data.\n\nAll participants have the right to refuse further participation in the study at any time.",[19,20,21],"Androgenic Alopecia","Hair Loss\u002FBaldness","Hair Thinning",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},40,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"OTHER","Xtressé Hair Growth Gummies","The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. The dosage is 2 gummies taken once per day.",[36],"Xtressé Nutraceutical Supplement Active",[38,42,45],{"measure":39,"description":40,"timeFrame":41},"Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis","Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements. Measurements of density as measured hair per cm².","From enrollment to the end of treatment at 6 months",{"measure":43,"description":44,"timeFrame":41},"Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis","Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus\u002Fterminal ratio.",{"measure":46,"description":47,"timeFrame":41},"Hair Density Changes measured by SOCAi","Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.",[49],{"measure":50,"description":51,"timeFrame":52},"Incidence of Adverse Events associated with Treatment","Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement","From first treatment until the end of treatment at 6 months","MALE","18 Years","65 Years",{"inclusion":57,"exclusion":62,"raw_text":67},[58,59,60,61],"Males aged 18-65","Norwood III to IV, vertex focused","Fitzpatrick skin type I to VI","Ability and willingness to comply with study protocol",[63,64,65,66],"Change in other hair treatments in 3 months prior to study enrollment.","Known uncontrolled health conditions.","History of hair or scalp disorders that could interfere with study results.","History of metabolic syndrome.","Inclusion Criteria:\n\n* Males aged 18-65\n* Norwood III to IV, vertex focused\n* Fitzpatrick skin type I to VI\n* Ability and willingness to comply with study protocol\n\nExclusion Criteria:\n\n* Change in other hair treatments in 3 months prior to study enrollment.\n* Known uncontrolled health conditions.\n* History of hair or scalp disorders that could interfere with study results.\n* History of metabolic syndrome.",[69,70],"ADULT","OLDER_ADULT",[72,89],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Advanced Dermatology & Cosmetic Surgery","Maitland","Florida","32751","United States",[79,83],{"name":80,"role":81,"email":82},"Dr. Priya Pohani","CONTACT","DrPPohani@adcsclinics.com",{"name":84,"role":85},"Matt Leavitt, DO","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},28.62778,-81.36312,{"facility":73,"city":90,"state":75,"zip":91,"country":77,"contacts":92,"geoPoint":99},"Port Orange","32127",[93,97],{"name":94,"role":81,"phone":95,"email":96},"Kiya Arbogast","386-322-8310","DrCDunn@adcsclinics.com",{"name":98,"role":85},"Charles Dunn, MD",{"lat":100,"lon":101},29.13832,-80.99561,[103],{"name":104,"role":81,"phone":105,"email":106},"Dr. Matt Leavitt, DO","321-594-6851","matt@xtresse.com",[108],{"name":109,"affiliation":13,"role":110},"Melissa Y Rayner, MS","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":116},[115],"Male pattern alopecia",[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study planning to enroll 40 male participants. It will evaluate the effects of Xtressé Hair Growth Gummies.","completed","Study of Xtressé Gummy Supplement for Hair Loss in Men","This study is looking for men aged 18-65 with a specific type of hair loss (androgenic alopecia, or male pattern baldness) to test a new gummy supplement called Xtressé Hair Growth Gummies. These gummies contain a special blend of plant extracts and regenerative compounds. The goal is to see if taking two gummies daily for six months can safely and effectively improve hair growth, thickness, and density. Researchers will use special photographic analysis to measure changes in your hair and will also ask about your satisfaction. They will also monitor for any side effects. The study plans to enroll 40 participants, but its current recruitment status is unclear.","Your hair density and thickness will be measured from enrollment to the end of treatment at 6 months.",108,"You would have three visits over six months, receiving a 90-day supply of gummies at the first two visits. You'll take the gummies daily, keep a treatment diary, and have photographs and scalp analysis done at each visit.","Not stated in the trial record.",[33],"v2"]