A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
CSEDSSDMP
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedJuly 25, 2025
July 1, 2025
3 months
June 12, 2025
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Reactions
Evaluate through skin response sheets: erythema, pain, swelling, etc.
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).
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.
Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.
Secondary Outcomes (2)
Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire
Assessed at 2 weeks post-application.
Number of participants with abnormal laboratory tests results
Assessed at 2 weeks post-application.
Other Outcomes (1)
Frequency of both local and systemic Adverse Events
2 weeks
Study Arms (4)
Microneedle with Saline
PLACEBO COMPARATORThis 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
EXPERIMENTALThis 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
EXPERIMENTALThis 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
EXPERIMENTALThis 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
July 25, 2025
Study Start
July 31, 2025
Primary Completion
October 31, 2025
Study Completion (Estimated)
May 31, 2026
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share