NCT07085520Not yet recruitingPhase 1
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Osteoporosis
- NCT number
- NCT07085520
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 31 Jul 2025 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals receiving systemic or local treatments that affect skin homeostasis.
Other illness
- 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).
Age
- Smoking \>10 cigarettes per day or smoking history \>20 years.
Other
- Pregnant or breastfeeding women.
- Contraindications for denosumab (e.g., hypocalcemia).
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.