IRCT20240416061507N2尚未招募4 期
Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in management of superficial lipomas
Espad pharmed0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years(—)
- 性别
- All
入选标准
- •having at least one lipoma (clinically and sonographically proven) and accessible for diagnostic and therapeutic approaches with at least two vertical axes measurable and with the following conditions:The history of gradual growth, stability in the last 6 months, single and isolated, with an oval to circular shape, without a hard consistency or connection to the underlying tissue, in the areas of the limbs and trunk and away from sensitive vascular-neural structures
- •Weight stability and body mass index less than 30 in the last 3 months
- •Ability to complete the study and follow instructions
- •Informed consent to participate in the study
- •Consent not to undergo any other intervention for lipoma during the study period
排除标准
- •Severe medical or psychological conditions that interfere with study results
- •History of hypersensitivity to any of the components of the studied product
- •Pregnancy and breastfeeding
- •History of previous lipoma treatment
- •Patients prone to intravascular volume depletion
- •Evidence of recent alcohol consumption or drug abuse
- •History of bleeding disorders or recent intake (less than 3 weeks) of thrombolytic drugs, anticoagulants, platelet inhibitors, or NSAIDs
- •History of hypertrophic scarring
- •Infection, inflammation, dermatosis, non-healing wound, cancer or precancerous lesions at the lipoma site
研究者
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