A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07085520
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 25, 2025
Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Oct 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Participants With Adverse Reactions [ Time Frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application. ]

Central Contacts

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