[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599517":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":41,"centralContacts":48,"locations":54,"responsibleParty":70,"collaborators":41,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":41,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":41,"overallStatus":96,"whyStopped":41,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Microneedle with Saline","PLACEBO_COMPARATOR","This study arm uses microneedle patches loaded with saline as a control to assess the skin safety of the microneedle patches. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[13],"Drug: Saline Microneedle Patch",{"label":15,"type":16,"description":17,"interventionNames":18},"Microneedle with 0.24mg Denosumab","EXPERIMENTAL","This study arm uses microneedle patches loaded with 0.24mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[19],"Drug: Microneedle with 0.24mg Denosumab",{"label":21,"type":16,"description":22,"interventionNames":23},"Microneedle with 1.2mg Denosumab","This study arm uses microneedle patches loaded with 1.2mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[24],"Drug: Microneedle with 1.2mg Denosumab",{"label":26,"type":16,"description":27,"interventionNames":28},"Microneedle with 6mg Denosumab","This study arm uses microneedle patches loaded with 6mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[29],"Drug: Microneedle with 6mg Denosumab",[31,37,42,45],{"type":32,"name":15,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","This intervention uses microneedle patches loaded with 0.24mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[15],[36],"Soluble Denosumab Microneedle Patch",{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Saline Microneedle Patch","This intervention involves the use of a microneedle patch loaded with saline. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It serves as a control to assess the skin safety of the microneedle patch without the active drug. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[9],null,{"type":32,"name":21,"description":43,"armGroupLabels":44,"otherNames":41},"This intervention uses microneedle patches loaded with 1.2mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[21],{"type":32,"name":26,"description":46,"armGroupLabels":47,"otherNames":41},"This intervention uses microneedle patches loaded with 6mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.",[26],[49],{"name":50,"role":51,"phone":52,"phoneExt":41,"email":53},"Wei Tong","CONTACT","86 13437105155","tongwei312@hust.edu.cn",[55],{"facility":56,"status":41,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Wuhan Union Hospital","Wuhan","Hubei","430022","China","CN",{"type":63,"coordinates":64},"Point",[65,66],114.26667,30.58333,{"lat":66,"lon":65},[69],{"name":50,"role":51,"phone":52,"phoneExt":41,"email":53},{"type":71,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100599517","phase-1-a-clinical-study-evaluating-the-dermal-safety-of-soluble-denosumab-microneedle-patches-100599517",false,"NCT07085520","A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches","CSEDSSDMP","Inclusion Criteria:\n\n1. Signed and dated informed consent.\n2. Commitment to comply with the study protocol and cooperate throughout the study.\n3. Age 18-70, healthy or adult male or female with osteoarthritis combined with osteoporosis.\n4. No history of skin diseases or other underlying conditions.\n5. No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones, or immunosuppressants within the past month.\n6. If of childbearing age, women must have used contraception for at least one month before screening and commit to using contraception throughout the study period and for a specified time after the study ends.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Smoking \\>10 cigarettes per day or smoking history \\>20 years.\n3. Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history.\n4. Individuals receiving systemic or local treatments that affect skin homeostasis.\n5. Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).\n6. Contraindications for denosumab (e.g., hypocalcemia).",true,"ALL","18 Years","70 Years",{"count":84,"type":85},12,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The goal of this clinical trial is to evaluate the skin safety of a soluble denosumab microneedle patch in participants with osteoporosis and osteoarthritis. The main questions it aims to answer are:\n\n* Is the soluble denosumab microneedle patch safe for use on the skin?\n* What are the potential skin reactions to the patch?\n\nResearchers will compare different doses of the microneedle patch to assess its safety.\n\nParticipants will:\n\n* Apply the microneedle patch to four different areas around their knee\n* Undergo skin assessments at various time points after application\n* Be monitored for any adverse skin reactions\n\nThe study will take place at a single center and involve a small number of participants to provide preliminary data on the safety of this novel drug delivery system.",[91,92,93,94,95],"Osteoarthritis","Osteoarthritis (OA) of the Knee","Osteoporosis","Osteoporosis (Senile)","Healthy","NOT_YET_RECRUITING","2025-07-17",{"date":99,"type":100},"2025-07-25","ACTUAL",{"date":102,"type":85},"2025-07-31",{"date":104,"type":85},"2026-05-31",{"name":5,"class":6},1]