Tests skin safety of a denosumab patch in adults with osteoporosis or knee osteoarthritis
Tests a dissolving skin patch with denosumab in adults with osteoporosis or knee osteoarthritis.
Plain-language title generated from the registry record
Registry title: A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults, or adults with knee osteoarthritis and osteoporosis, to test the skin safety of a denosumab microneedle patch.
- Age
- 18 to 70 years.
- Sex
- Men and women can join.
- Disease stage
- Healthy, or adult with osteoarthritis together with osteoporosis. No history of skin diseases or other underlying conditions.
- Earlier treatment
- No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones or immunosuppressants in the past month.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Smoking more than 10 cigarettes per day, or smoking for more than 20 years
- Allergy or intolerance to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA)
- Contraindications for denosumab, for example hypocalcemia
- Treatments that affect skin homeostasis
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07085520, who can take part
Where in China
- Wuhan Union HospitalWuhan, ChinaContact: Wei TongNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT07085520
- Record updated
- 25 July 2025
- Original description
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:Read full original descriptionShow less
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
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.
Inclusion: 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: Individuals receiving systemic or local treatments that affect skin homeostasis; Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history; Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA); Smoking >10 cigarettes per day or smoking history >20 years; Pregnant or breastfeeding women; Contraindications for denosumab (e.g., hypocalcemia).