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

Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Phase 1

Conditions: Osteoporosis; Healthy; Osteoarthritis; Osteoporosis (Senile); Osteoarthritis (OA) of the Knee

Treatments: Drug: Saline Microneedle Patch; Drug: Microneedle with 6mg Denosumab; Drug: Microneedle with 1.2mg Denosumab; Drug: Microneedle with 0.24mg Denosumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07085520

20250379

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Microneedle with Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline Microneedle Patch

Microneedle with 0.24mg Denosumab

Experimental group

Description:

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.

Treatment:

Drug: Microneedle with 0.24mg Denosumab

Microneedle with 1.2mg Denosumab

Experimental group

Description:

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.

Treatment:

Drug: Microneedle with 1.2mg Denosumab

Microneedle with 6mg Denosumab

Experimental group

Description:

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.

Treatment:

Drug: Microneedle with 6mg Denosumab