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NCT Number: NCT07085520

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.

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Key information

Conditions

Osteoarthritis Arthritis Bone Diseases Bone Diseases, Metabolic Healthy Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis (OA) of the Knee Osteoporosis Osteoporosis (Senile) Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Microneedle with 0.24mg Denosumab

Drug

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.

Other names: Soluble Denosumab Microneedle Patch

Saline Microneedle Patch

Drug

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 Denosumab

Drug

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 Denosumab

Drug

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire

    Time frame: Assessed at 2 weeks post-application.

    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

  2. Number of participants with abnormal laboratory tests results

    Time frame: Assessed at 2 weeks post-application.

    Evaluation of blood routine and blood electrolytes to monitor participants' health status and safety.

Other outcomes

  1. Frequency of both local and systemic Adverse Events

    Time frame: 2 weeks

    An adverse event is any adverse change from the subject's baseline condition, i.e. any subjective signs and symptoms, or change in a concomitant disease present at the screening visit. This includes inter-current signs, symptoms, illness and significant deviations from baseline which may occur during the course of the clinical study, whether considered related to treatment or not.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Tong

CONTACT

[email protected]

86 13437105155

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Acronym: CSEDSSDMP

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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