Pilot Study to Evaluate the Safety and Efficacy of 3.2% High (HHA) and Low (LHA) Molecular Weight Hyaluronic Acid Sodium Salt [32 Mg (HHA) + 32 Mg (LHA) / 2 Ml] for Intralesional Penile Injection in Peyronie's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of HiLow hyaluronic acid sodium salt for intralesional penile injection in patients affected by PD.
详细描述
Prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of HiLow hyaluronic acid sodium salt for intralesional penile injection in patients affected by PD.
Fourty patients aged 18-75 and affected by PD in the acute phase will be enrolled in the study.
The primary endpoint is the incidence of adverse events with causal relationship during the 2.5 months of active treatment and during follow-up.
The scondary endpoint is the overall improvement of the clinical condition by evaluation of the patient's global improvement (PGI-I scale), the amelioration in the degree of the curvature of the penis and the amelioration in the length of the penis after the induction of penile erection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •basal degree of penile curvature not less than 30°
- •preserved erection
- •documented absence of coagulation defects (at least one examination of coagulation factors within the 3 months prior to the start of the study)
- •written informed consent
排除标准
- •presence of hourglass deformity
- •presence of calcified plaques
- •congenital curvature of the penis
- •previous penile surgery
- •concomitant oral treatment for IPP
- •ongoing intralesional therapy or in the 3 months prior to the start of the study
- •use of any traction device
- •clinically stable disease
- •history of symptomatic disease > 12 months
- •known hypersensitivity or allergies to the components of the product
- •any other clinical condition judged by the investigator not to be compatible with the participation in this study
结局指标
主要结局
Incidence of adverse events
时间窗: From Day 0 to Day 180
Evaluation of the safety of the treatment by measurement of the incidence of adverse events
次要结局
- Penile curvature(Day 0, Day 75, Day 180)
- Penile length(Day 0, Day 75, Day 180)
- Patient's global impression of improvement(Day 75, Day 180)