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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:
Researchers will compare different doses of the microneedle patch to assess its safety.
Participants will:
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Microneedle with 1.2mg Denosumab | Experimental | 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. |
|
| Microneedle with 6mg Denosumab | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle with 0.24mg Denosumab | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Reactions | Evaluate through skin response sheets: erythema, pain, swelling, etc. | Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application. |
| Amount of pain | Pain will be measured using the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain). | Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application. |
| Number of injection site reactions | Injection site assessment for the following: Pain (grade 1/2/3) Tenderness (grade 1/2/3) Pruritus (grade 1/2/3) Erythema (absent/present) Induration (grade 1/2/3) Blister (absent/present) Ulceration (absent/present) Necrosis (absent/present) Ecchymosis (absent/present) If any of these signs or symptoms is present, it is regarded an injection site reaction. | Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application. |
| Measure | Description | Time Frame |
|---|---|---|
| Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire | Assessed through questionnaires at the end of the study.
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of both local and systemic Adverse Events | An adverse event is any adverse change from the subject's baseline condition, i.e. any subjective signs and symptoms, or change in a concomitant disease present at the screening visit. This includes inter-current signs, symptoms, illness and significant deviations from baseline which may occur during the course of the clinical study, whether considered related to treatment or not. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Tong | Contact | 86 13437105155 | tongwei312@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2025 |
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|
|
| Saline Microneedle Patch | Drug | 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. |
|
| Microneedle with 1.2mg Denosumab | Drug | 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. |
|
| Microneedle with 6mg Denosumab | Drug | 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. |
|
| Assessed at 2 weeks post-application. |
| Number of participants with abnormal laboratory tests results | Evaluation of blood routine and blood electrolytes to monitor participants' health status and safety. | Assessed at 2 weeks post-application. |
| 2 weeks |
| Jul 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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