A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microneedle with 0.24mg Denosumab, Saline Microneedle Patch, Microneedle with 1.2mg Denosumab, Microneedle with 6mg Denosumab.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis, Osteoporosis (Senile). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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: * 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.
Interventions
- Drug 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. - Drug 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. - Drug 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. - Drug 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.
Primary outcome measures
- Number of Participants With Adverse Reactions [Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]
- Amount of pain [Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]
- Number of injection site reactions [Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]
Secondary outcome measures (2)
- Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire [Time frame: Assessed at 2 weeks post-application.]
- Number of participants with abnormal laboratory tests results [Time frame: Assessed at 2 weeks post-application.]
Eligibility criteria
Inclusion criteria
- Signed and dated informed consent.
- Commitment to comply with the study protocol and cooperate throughout the study.
- Age 18-70, healthy or adult male or female with osteoarthritis combined with osteoporosis.
- No history of skin diseases or other underlying conditions.
- No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones, or immunosuppressants within the past month.
- 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
- Pregnant or breastfeeding women.
- Smoking >10 cigarettes per day or smoking history >20 years.
- Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history.
- Individuals receiving systemic or local treatments that affect skin homeostasis.
- Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).
- Contraindications for denosumab (e.g., hypocalcemia).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
China · 1 center
- Wuhan Union Hospital — Wuhan
Identifiers
NCT: NCT07085520 · 20250379