A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches (NCT07085520) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
China12 participantsStarted 2025-07-31
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
What they're measuring
1
Number of Participants With Adverse Reactions
Timeframe: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
2
Amount of pain
Timeframe: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
3
Number of injection site reactions
Timeframe: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Trial details
NCT IDNCT07085520
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology