A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Reactions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Microneedle with Saline
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.
干预措施: Saline Microneedle Patch (Drug)
Microneedle with 0.24mg Denosumab
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.
干预措施: Microneedle with 0.24mg Denosumab (Drug)
Microneedle with 1.2mg Denosumab
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.
干预措施: Microneedle with 1.2mg Denosumab (Drug)
Microneedle with 6mg Denosumab
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.
干预措施: Microneedle with 6mg Denosumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Reactions
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)