Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the Anterior and Posterior Aspect of the Axilla "Bra Strap Fat"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reduction of Anterior/Posterior Axilla Fat
研究概览
简要总结
This study evaluates the safety and efficacy of deoxycholic acid injections to dissolve adipose tissue in the anterior and posterior aspect of the axilla or the so called "brassiere strap fat" (BSF). Adult females aged 18-65 dissatisfied with their moderate or severe BSF will receive deoxycholic acid (dose strength: 2 mg/cm2) via subcutaneous injections into posterior and/or anterior axillary roll adiposity .
详细描述
The efficacy and safety of deoxycholic acid injections to dissolve adipose tissue in the submental area have been extensively evaluated. Deoxycholic acid injections have also been used successfully off-label to dissolve adipose tissues in other body areas. Our clinical experience in addition to a few case reports have shown the effectiveness and safety of deoxycholic acid injections to dissolve the adipose tissue in the anterior and posterior aspect of the axilla or the so called "brassiere strap fat" (BSF).
This is a single-center, prospective, single-arm, single-blind trial study.
This study is expected to benefit the existing literature by potentially adding a new non-invasive injectable treatment to a condition of excessive adipose tissue in the anterior and posterior aspect of the axilla that until now could only be treated with invasive surgery.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult female age 18-65
- •Subject satisfaction rating score of 0 or 1
- •Clinician reported BSF rating score of 2, 3 or 4
- •Patient reported BSF rating score of 2, 3 or 4
- •Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- •Willing to withhold additional aesthetic therapies to the proposed treatment area.
- •Negative urine pregnancy test
- •Willing to use acceptable methods of contraception throughout the study
- •Sign an IRB-approved Informed Consent Form prior to any study-related procedures being performed.
排除标准
- •History of any intervention to treat BSF (eg, liposuction, surgery, lipolytic agents)
- •History of trauma associated with the axillary or upper back area
- •Severe Skin Laxity Grade or other anatomical feature as assessed within 28 d before randomization, for which reduction in BSF may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
- •Evidence of any cause of enlargement in the upper back/ axillary roll (eg, tumors, lipomas) other than localized BSF
- •BMI greater than 35 kg/m2
- •A result on coagulation tests (prothrombin time, partial thromboplastin time) obtained within 28 d before randomization indicating the presence of any clinically significant bleeding disorder
- •Any medical condition (eg, respiratory, cardiovascular, hepatic, neurologic disease, thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the patient's ability to undergo study procedures or give informed consent
- •History of sensitivity to any components of the study drug
- •History of sensitivity to topical or local anesthetics (eg, lidocaine, benzocaine, procaine)
- •Pregnancy
- •Lactation
- •Presence of infection at the injection sites
研究组 & 干预措施
Open-Label: Deoxycholic Acid Injections
Deoxycholic Acid Injections (dose strength: 2 mg/cm2) via subcutaneous injections into posterior and/or anterior axillary roll adiposity. Patients will receive 10 mL or less (≤100 mg) of study drug per treatment administered in 0.2-mL injections with a 30-gauge, 0.5-in needle attached to a 1-mL syringe at 1.0-cm spacing using a customized grid. Up to 6 treatments (30 ± 7 days apart) will be permitted, but fewer can be allowed because of efficacy (insufficient BSF to inject, patient satisfaction with treatment) or safety/tolerability concerns.
干预措施: Deoxycholic Acid (Drug)
结局指标
主要结局
Reduction of Anterior/Posterior Axilla Fat
时间窗: 6 months
Composite improvements of 1 or more grades in BSF observed on both the Clinician- and Patient-Reported BSF Rating Scales
次要结局
未报告次要终点
研究者
Bruce E. Katz
Medical Director
Juva Skin & Laser Center