[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626588":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":53,"studyPopulation":11,"armGroups":54,"interventions":64,"overallOfficials":11,"centralContacts":74,"locations":80,"responsibleParty":100,"collaborators":11,"id":102,"slug":11,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Hudson Biotech","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time to complete re-epithelialization (days) of each wound, defined as 100% epithelial coverage without drainage, confirmed by blinded clinical assessment and standardized photography.",null,"21 Days",[14,18,21,24,28,32,36],{"measure":15,"description":16,"timeFrame":17},"Percent wound area reduction","Assessed by digital planimetry from standardized photographs.","1 Day",{"measure":19,"description":20,"timeFrame":12},"Proportion of wounds healed","Binary outcomes derived from re-epithelialization assessment.",{"measure":22,"description":23,"timeFrame":12},"Incidence of suspected or confirmed wound infection","Assessed clinically; swab\u002Fculture if clinically indicated",{"measure":25,"description":26,"timeFrame":27},"Participant-reported wound pain","0-10 numeric rating scale recorded daily","14 Days",{"measure":29,"description":30,"timeFrame":31},"Local tolerability score","Erythema, burning\u002Fstinging, pruritus scored at each visit.","12 weeks",{"measure":33,"description":34,"timeFrame":35},"Scar quality (POSAS)","Patient and Observer Scar Assessment Scale","12 Weeks",{"measure":37,"description":38,"timeFrame":39},"Safety","Treatment-emergent adverse events (local\u002Fsystemic), serious adverse events, and withdrawals due to adverse events.","14 days",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":11,"timePerspective":11,"maskingInfo":45},"RANDOMIZED","PARALLEL","Each participant receives two standardized wounds; one wound is randomized to GHK-Cu gel and the other to vehicle gel. This paired design controls for participant-level factors (e.g., age, genetics) that influence healing.","TREATMENT",{"masking":46,"maskingDescription":47,"whoMasked":48},"QUADRUPLE","GHK-Cu and vehicle gels are identical in appearance, packaging, and labeling. Randomization codes are held by an independent pharmacist\u002Fbiostatistician. Blinded assessors evaluate standardized photographs.",[49,50,51,52],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","GHK (glycyl-L-histidyl-L-lysine) is a naturally occurring human peptide that can form a stable complex with copper(II) (GHK-Cu). Preclinical and mechanistic literature suggests GHK-Cu may influence processes relevant to tissue repair such as extracellular matrix remodeling, angiogenesis, and inflammation. This proof-of-concept study uses a standardized acute wound model (paired punch-biopsy wounds) to reduce variability and enable a controlled comparison. Study objectives Primary objective: Determine whether topical GHK-Cu gel reduces time to complete re-epithelialization versus vehicle. Secondary objectives: Evaluate wound area reduction over time, local symptoms (pain\u002Fitch), infection rate, scar quality at 12 weeks, and safety\u002Ftolerability. Study procedures (overview) Day 0: Two 5-mm punch-biopsy wounds will be created under local anesthetic on the non-dominant upper arm. Wounds will be randomized (1:1) to receive GHK-Cu gel or vehicle gel. Study products will be applied once daily for 14 days under standardized non-adherent dressings. Follow-up: In-clinic assessments with standardized digital photography and clinical evaluation on Days 3, 7, 10, 14, and 21 (or until healed). Remote check-ins may be used for interim safety and adherence.\n\nWeek 12: Scar assessment (POSAS) and final safety review.",[55,61],{"label":56,"type":57,"description":11,"interventionNames":58},"Arm A: GHK-Cu Gel (0.1% w\u002Fw) applied once daily to the assigned wound for 14 days + standard non-adh","EXPERIMENTAL",[59,60],"Drug: GHK-Cu Gel (Copper(II)-peptide complex)","Drug: vehicle Gel (placebo comparator)",{"label":62,"type":57,"description":11,"interventionNames":63},"Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres",[59,60],[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"DRUG","GHK-Cu Gel (Copper(II)-peptide complex)","topical gel, 0.1% w\u002Fw; apply a thin film (approx. 0.5 g) once daily for 14 days.",[56,62],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"vehicle Gel (placebo comparator)","ehicle Gel (placebo comparator",[56,62],[75],{"name":76,"role":77,"phone":78,"phoneExt":11,"email":79},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":90,"coordinates":91},"Point",[92,93],114.0683,22.54554,{"lat":93,"lon":92},[96],{"name":97,"role":77,"phone":98,"phoneExt":11,"email":99},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100626588",false,"NCT07437586","Topical GHK-Cu Gel for Acute Skin Wound Healing","A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Split-Wound Study of Topical GHK-Cu (Copper(II)-Peptide Complex) Gel to Accelerate Re-Epithelialization of Standardized Acute Skin Wounds in Healthy Adults","CuHeal","Inclusion Criteria:\n\n* Age 18 to 55 years at screening.\n* Healthy adult as determined by medical history and limited physical examination.\n* Body mass index (BMI) 18.0 to 30.0 kg\u002Fm².\n* Willing and able to comply with study visits and daily product application for 14 days.\n* Willing to avoid applying non-study topical products (including medicated creams, retinoids, acids) to the wound area during the study period.\n* For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception through Day 21.\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to copper, peptides, gel excipients, adhesives, or dressings used in the study.\n* History of abnormal wound healing, hypertrophic scarring, or keloid formation.\n* Clinically significant dermatologic disease near the intended wound site (e.g., eczema, psoriasis, active infection).\n* Diabetes mellitus, peripheral vascular disease, immunodeficiency, or other condition that may impair wound healing (investigator judgment).\n* Use of systemic corticosteroids, immunosuppressants, or cytotoxic medications within 30 days prior to Day 0.\n* Current smoker or nicotine use (including vaping) within the past 3 months.\n* Pregnant or breastfeeding.\n* Participation in another interventional clinical study within 30 days prior to screening.\n* Any condition that, in the investigator's opinion, would make participation unsafe or could interfere with study assessments.",true,"ALL","18 Years","55 Years",{"count":114,"type":115},60,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","This study will evaluate whether a topical gel containing GHK-Cu (a copper(II)-peptide complex) can safely speed up healing of small, standardized skin wounds in healthy adults compared with a matching vehicle gel.\n\nParticipants will receive two small punch-biopsy wounds on the upper arm; each wound will be randomly assigned to receive GHK-Cu gel or vehicle gel under identical dressings. Wounds will be photographed and assessed over 3 weeks, with a follow-up visit to evaluate scar quality.",[121],"Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds)",[123,124,125,126,127,128,129,130],"GHK-Cu","copper peptide","Copper(II)-peptide complex","copper tripeptide-1","wound healing","re-epithelialization","skin repair","scar quality","2026-02-22",{"date":133,"type":134},"2026-02-27","ACTUAL",{"date":136,"type":134},"2026-02-02",{"date":138,"type":115},"2028-03-17",{"name":5,"class":6},1]