Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
详细描述
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
- •History of slow growth followed by dormancy, and stable for at least 6 months
- •Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
- •Discrete, oval to rounded in shape, not hard or attached to underlying tissue
- •Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
- •Located on the trunk, arms, legs, or neck
- •Signed informed consent.
排除标准
- •Absence of significant medical conditions that could affect safety
- •History of surgical or deoxycholate treatment for lipomas
- •Treatment with an investigational agent within 30 days before ATX-101 treatment
研究组 & 干预措施
Deoxycholic Acid 1%
Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Deoxycholic Acid 2%
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Deoxycholic Acid 4%
Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
干预措施: Deoxycholic Acid Injection (Drug)
Placebo
Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 24 weeks
Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard.
Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities
时间窗: 24 weeks
An abnormality is defined as a value outside the limits of the expanded normal range/notable range.
Number of Participants With Clinically Significant Changes in Vital Signs or Weight
时间窗: Up to 24 weeks
Number of Participants With Positive Histopathology Results at Screening
时间窗: Screening (prior to randomization)
A needle core tissue sample biopsy was performed at screening for all treated lipomas.
Number of Participants With Positive Histopathology Results at Week 20
时间窗: Week 20
After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.
次要结局
- Percentage of Participants With Complete Clearance or ≥ 75% Clearance(Baseline and week 20 (8 weeks after last dose))
- Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas(Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment))