Clinical Trial

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

Study acronym: CSEDSSDMP
Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated July 25, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07085520
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis, Osteoporosis (Senile), Healthy
Enrollment 12 participants
Start Date 2025-07-31
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-25