NCT07004010已完成不适用
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat
Espad Pharmed2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12
研究概览
简要总结
Flank region fat is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid was approved by the American FDA for treatment of flank fat. The purpose of this study is to evaluate the efficacy and safety of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.
The Primary objective of this study was the proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 Secondary objective was assessment of other efficacy parameters as well as safety of the product
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having mild to moderate flank fat assessed by the investigator and sonography and/or caliper (≥2cm thickness of the fat tissue in posterior axillary lines at the level of ASIS)
- •Signing informed consent by the subject
- •Ability to follow study instructions and likely to complete all required visits
- •Agreement to abstain from any treatment to the flank region, including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc., during the study
排除标准
- •Planning to change lifestyle within the projected duration of the trial
- •History of liposuction surgery or laser lipolysis in the past 12 months or planning to have these procedures
- •Significant weight reduction in the past 6 months or planning for weight reduction within the projected duration of the trial
- •BMI > 30 kg/m2
- •Waist circumference > 105 cm
- •Uncontrolled systemic diseases
- •Severe cardiovascular diseases
- •Known allergy or sensitivity to the study medication or its components
- •Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial
- •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
- •Previous treatment to the flanks with hyaluronic acid fillers or semi-permanent filler in the past 12 months
- •Use of any permanent filler materials or silicone in the flanks
- •Subjects planning a cosmetic procedure in the treatment area during the study or with prior cosmetic procedures (i.e., surgery) in the treatment area or visible scars that may affect the evaluation
- •Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease
- •Infection or dermatoses at the injection site
- •Evidence of recent alcohol or drug abuse
- •Medical and/or psychiatric problems that are severe enough to interfere with the study results
- •Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
- •Having hair that would interfere with evaluation and treatment of the flank area
- •Being prone to develop hypertrophic scarring
- •Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
- •Having porphyria
- •Having an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the flank area
- •Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
结局指标
主要结局
The proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12
时间窗: Week 12
A comparison between Week 12 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
次要结局
- Safety assessment by evaluation of adverse events (AEs)(Baseline, Week 6, Week 12)
- Change from Baseline in ultrasonographic measurement of dermal and hypodermal thickness on both flanks at weeks 6 and 12(Baseline, Week 6, Week 12)
- The proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 6(Week 6)
- Changes from Baseline in the bodyweight (Kg) at Weeks 6 and 12(Baseline, Week 6, Week 12)
- Changes from Baseline in right and left thigh circumference at Weeks 6 and 12 using a flexible tape measure(Baseline, Week 6, Week 12)
- Changes from Baseline in caliper measurement (mm) of flank fat on each side at Weeks 6 and 12(Baseline, Week 6, Week 12)
- Changes from Baseline in waist circumference at Weeks 6 and 12 using a flexible tape measure(Baseline, Week 6, Week 12)
- Subject's satisfaction at Weeks 6 and 12 using a 10-point Likert scale(Week 6, Week 12)
研究者
研究点 (2)
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