A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
NCT ID: NCT07085520
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-07-31
2026-05-31
Brief Summary
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* Is the soluble denosumab microneedle patch safe for use on the skin?
* What are the potential skin reactions to the patch?
Researchers will compare different doses of the microneedle patch to assess its safety.
Participants will:
* Apply the microneedle patch to four different areas around their knee
* Undergo skin assessments at various time points after application
* Be monitored for any adverse skin reactions
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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Microneedle with Saline
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.
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.
Microneedle with 0.24mg Denosumab
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 0.24mg Denosumab
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.
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.
Microneedle with 1.2mg Denosumab
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
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.
Microneedle with 6mg Denosumab
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.
Interventions
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Microneedle with 0.24mg Denosumab
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.
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.
Microneedle with 1.2mg Denosumab
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Commitment to comply with the study protocol and cooperate throughout the study.
3. Age 18-70, healthy or adult male or female with osteoarthritis combined with osteoporosis.
4. No history of skin diseases or other underlying conditions.
5. No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones, or immunosuppressants within the past month.
6. 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.
Exclusion Criteria
2. Smoking \>10 cigarettes per day or smoking history \>20 years.
3. Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history.
4. Individuals receiving systemic or local treatments that affect skin homeostasis.
5. Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).
6. Contraindications for denosumab (e.g., hypocalcemia).
18 Years
70 Years
ALL
Yes
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20250379
Identifier Type: -
Identifier Source: org_study_id
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