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

Обзор

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.

Вмешательства

• Препарат Microneedle with 0.24mg Denosumab
  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.
• Препарат Saline Microneedle Patch
  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.
• Препарат Microneedle with 1.2mg Denosumab
  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.
• Препарат Microneedle with 6mg Denosumab
  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.

Первичные конечные точки

• Number of Participants With Adverse Reactions [Срок оценки: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]
• Amount of pain [Срок оценки: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]
• Number of injection site reactions [Срок оценки: Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.]

Вторичные конечные точки (2)

• Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire [Срок оценки: Assessed at 2 weeks post-application.]
• Number of participants with abnormal laboratory tests results [Срок оценки: Assessed at 2 weeks post-application.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Wuhan Union Hospital — Ухань

Идентификаторы

NCT: NCT07085520 · 20250379

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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