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

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing the safety of a new type of patch that delivers a medicine called denosumab through tiny needles that dissolve into the skin. The study focuses on people who have osteoporosis (a condition that weakens bones) and osteoarthritis (joint pain and stiffness), especially around the knee. Researchers want to see if this patch is safe to use on the skin and whether it causes any skin reactions, like redness or irritation. Different doses of the patch will be tried to understand how the skin responds.

If you join the study, you’ll apply the patch to four different spots around your knee. Your skin will be checked several times after using the patch to look for any reactions or side effects. The study will be done at one location and will include a small group of adults between 18 and 70 years old who are generally healthy or have both osteoporosis and osteoarthritis. People with certain skin conditions, allergies, or other health issues won’t be able to join. Women who can become pregnant need to use birth control during the study. Overall, this study aims to gather early information about how safe and gentle this new patch treatment is on the skin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent.
• • 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:
• • 1. Pregnant or breastfeeding women.
• • 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).