OsteoarthritisPhase 1CSEDSSDMPNCT07085520
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
A Phase 1 study testing Microneedle with 0.24mg Denosumab, Saline Microneedle Patch and Microneedle with 1.2mg Denosumab in people with Osteoarthritis and Osteoarthritis (OA) of the Knee, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis
- What is being tested?
- Microneedle with 0.24mg Denosumab, Saline Microneedle Patch and Microneedle with 1.2mg Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 31 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Individuals receiving systemic or local treatments that affect skin homeostasis.
- Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).
- Contraindications for denosumab (e.g., hypocalcemia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Wuhan Union Hospital
Wuhan, Hubei, 430022
Wei Tong, 86 13437105155, tongwei312@hust.edu.cn
About this study
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?
Read more
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.
- Conditions
- Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis, Osteoporosis (Senile), Healthy
- Being tested
- Microneedle with 0.24mg Denosumab, Saline Microneedle Patch, Microneedle with 1.2mg Denosumab, Microneedle with 6mg Denosumab
- Medical subject headings
- Osteoarthritis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle with 0.24mg DenosumabDrug
Also called Soluble Denosumab Microneedle Patch
This intervention uses microneedle patches loaded with 0.24mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.
Saline Microneedle PatchDrug
This intervention involves the use of a microneedle patch loaded with saline. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It serves as a control to assess the skin safety of the microneedle patch without the active drug. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.
Microneedle with 1.2mg DenosumabDrug
This intervention uses microneedle patches loaded with 1.2mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.
Microneedle with 6mg DenosumabDrug
This intervention uses microneedle patches loaded with 6mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.
| Study group | Role | What they receive |
|---|---|---|
| Microneedle with Saline | Placebo comparator | This study arm uses microneedle patches loaded with saline as a control to assess the skin safety of the microneedle patches. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. Receives: Drug: Saline Microneedle Patch |
| Microneedle with 0.24mg Denosumab | Experimental | This study arm uses microneedle patches loaded with 0.24mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. Receives: Drug: Microneedle with 0.24mg Denosumab |
| Microneedle with 1.2mg Denosumab | Experimental | This study arm uses microneedle patches loaded with 1.2mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. Receives: Drug: Microneedle with 1.2mg Denosumab |
| Microneedle with 6mg Denosumab | Experimental | This study arm uses microneedle patches loaded with 6mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. Receives: Drug: Microneedle with 6mg Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Reactions
Evaluate through skin response sheets: erythema, pain, swelling, etc.
Measured: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Amount of pain
Pain will be measured using the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain).
Measured: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Number of injection site reactions
Injection site assessment for the following:
Pain (grade 1/2/3) Tenderness (grade 1/2/3) Pruritus (grade 1/2/3) Erythema (absent/present) Induration (grade 1/2/3) Blister (absent/present) Ulceration (absent/present) Necrosis (absent/present) Ecchymosis (absent/present) If any of these signs or symptoms is present, it is regarded an injection site reaction.
Measured: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Secondary outcomes (2)
Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire
Assessed through questionnaires at the end of the study.
- How satisfied are you with the application process of the microneedle patch?
- How satisfied are you with the overall skin condition around the knee after using the microneedle patch?
- Overall, how satisfied are you with the ease of using the microneedle patch?
- Overall, now that you have tried this microneedle patch and completed the study, how likely are you to use this treatment again in the future?
- Overall, how likely are you to recommend this microneedle patch treatment to a family member or friend? 5 = Very Likely; 4 = Somewhat Likely; 3 = Neutral; 2 = Somewhat Unlikely; 1 = Very Unlikely
Measured: Assessed at 2 weeks post-application.
Number of participants with abnormal laboratory tests results
Evaluation of blood routine and blood electrolytes to monitor participants' health status and safety.
Measured: Assessed at 2 weeks post-application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085520
- Sponsor's protocol ID
- 20250379
- Acronym
- CSEDSSDMP
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
- ClinicalTrials.gov ID
- NCT07085520
- Acronym / sponsor ID
- CSEDSSDMP / 20250379
- Conditions
- Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis, Osteoporosis (Senile), Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microneedle with Saline | Placebo comparator | Drug: Saline Microneedle PatchThis study arm uses microneedle patches loaded with saline as a control to assess the skin safety of the microneedle patches. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. |
| Microneedle with 0.24mg Denosumab | Experimental | Drug: Microneedle with 0.24mg DenosumabThis study arm uses microneedle patches loaded with 0.24mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. |
| Microneedle with 1.2mg Denosumab | Experimental | Drug: Microneedle with 1.2mg DenosumabThis study arm uses microneedle patches loaded with 1.2mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. |
| Microneedle with 6mg Denosumab | Experimental | Drug: Microneedle with 6mg DenosumabThis study arm uses microneedle patches loaded with 6mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Individuals receiving systemic or local treatments that affect skin homeostasis.
- Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle with 0.24mg DenosumabAlso: Soluble Denosumab Microneedle PatchThis intervention uses microneedle patches loaded with 0.24mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. | Drug | Microneedle with 0.24mg Denosumab |
| Saline Microneedle PatchThis intervention involves the use of a microneedle patch loaded with saline. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It serves as a control to assess the skin safety of the microneedle patch without the active drug. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. | Drug | Microneedle with Saline |
| Microneedle with 1.2mg DenosumabThis intervention uses microneedle patches loaded with 1.2mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. | Drug | Microneedle with 1.2mg Denosumab |
| Microneedle with 6mg DenosumabThis intervention uses microneedle patches loaded with 6mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study. | Drug | Microneedle with 6mg Denosumab |
Primary outcome
Number of Participants With Adverse Reactions
Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Evaluate through skin response sheets: erythema, pain, swelling, etc.
Amount of pain
Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Pain will be measured using the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain).
Number of injection site reactions
Time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Injection site assessment for the following: Pain (grade 1/2/3) Tenderness (grade 1/2/3) Pruritus (grade 1/2/3) Erythema (absent/present) Induration (grade 1/2/3) Blister (absent/present) Ulceration (absent/present) Necrosis (absent/present) Ecchymosis (absent/present) If any of these signs or symptoms is present, it is regarded an injection site reaction.
2 secondary outcomes
Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire
Time frame: Assessed at 2 weeks post-application.
Number of participants with abnormal laboratory tests results
Time frame: Assessed at 2 weeks post-application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microneedle with 0.24mg Denosumab, Saline Microneedle Patch and Microneedle with 1.2mg Denosumab in people with Osteoarthritis and Osteoarthritis (OA) of the Knee, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Tong (86 13437105155, tongwei312@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Reactions (time frame: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.