Efficacy, Satisfaction, and Safety of the Mesolipo® Protocol for the Treatment of Localized Adiposity (MESO-LA)
Eficácia,Satisfação e Segurança do Protocolo Mesolipo® no Tratamento da Gordura Localizada: um Estudo Randomizado
研究概览
详细说明
Introduction: The Mesolipo® Protocol is a promising alternative for the treatment of localized adiposity, a condition that may negatively affect self-esteem and quality of life. Combining the principles of mesotherapy and intralipotherapy, this minimally invasive method aims to reduce localized fat effectively and safely through the administration of lipolytic substances.
Objectives: This study aims to evaluate the efficacy, patient satisfaction, and safety of the Mesolipo® Protocol for the treatment of localized adiposity.
Methods: This is a controlled clinical study involving 12 participants. Each participant will receive the Mesolipo® treatment on one side of the body and placebo on the contralateral side, allowing an intra-individual comparison of outcomes. Efficacy will be assessed using skinfold measurements, standardized photographs, and the Global Aesthetic Improvement Scale. Patient satisfaction will be evaluated using specific questionnaires, while safety will be monitored through detailed documentation of adverse events and complications. Descriptive and analytical statistical analyses will be performed. The study will comply with ethical research principles and will begin only after approval by the Research Ethics Committee. Participation will be conditional upon signing the Informed Consent Form.
Expected Results: The study is expected to provide relevant evidence regarding the feasibility, efficacy, and safety of the Mesolipo® Protocol for the treatment of localized adiposity. The findings may support the development of new therapeutic options and contribute to improving the quality of life of individuals affected by this condition.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西、30493-240
- Instituto Antony Barbosa
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 18 years or older.
- Presence of localized adiposity suitable for treatment with the Mesolipo® protocol.
- Willingness and ability to provide written informed consent.
- Ability to comply with all study procedures and follow-up visits.
- Stable body weight for at least 3 months before enrollment.
- Agreement to maintain usual diet and physical activity habits throughout the study.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Known hypersensitivity to sodium deoxycholate or any study product component.
- Active infection or inflammatory skin disease at the treatment site.
- Previous aesthetic treatment in the target area within the period defined by the protocol.
- Severe systemic disease or any condition that, in the investigator's opinion, could interfere with study participation or outcome assessment.
- Participation in another clinical trial within the previous 30 days.
- Inability or unwillingness to comply with study procedures.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Mesolipo® Protocol
Participants will receive the Mesolipo® protocol on one side of the body for the treatment of localized adiposity.
The intervention consists of subcutaneous administration of the Mesolipo® formulation according to the standardized study protocol.
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Mesolipo® is an injectable formulation containing sodium deoxycholate administered by subcutaneous injection for the treatment of localized adiposity.
The intervention is applied according to a standardized protocol regarding dose, injection technique, and treatment schedule.
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有源比较器：Active Comparator
Participants will receive the comparator intervention on the contralateral side of the body.
The comparator consists of the control formulation administered using the same injection technique and treatment schedule as the experimental intervention.
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Pentoxifylline diluted in saline solution administered by subcutaneous injection using the same injection technique and treatment schedule as the experimental intervention.
This intervention serves as the active comparator.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Treatment efficacy
大体时间：Baseline to Day 90
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Assessed by the reduction in skinfold thickness measured using standardized skinfold calipers.
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Baseline to Day 90
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Treatment Safety
大体时间：Baseline to day 90
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Safety will be assessed by the occurrence, frequency, and severity of treatment-related adverse events.
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Baseline to day 90
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient satisfaction score assessed using a 5-point Likert satisfaction scale
大体时间：Day 90
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Patient satisfaction will be assessed using a standardized 5-point Likert satisfaction scale at Day 90.
Scores range from 1 (very dissatisfied) to 5 (very satisfied).
The mean satisfaction score will be reported.
Higher scores indicate greater patient satisfaction.
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Day 90
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Global Aesthetic Improvement Scale (GAIS) score
大体时间：Baseline and Day 90
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Aesthetic improvement will be assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS).
GAIS is a 5-point scale ranging from -2 (much worse) to +2 (very much improved).
The mean GAIS score will be reported.
Higher scores indicate greater aesthetic improvement.
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Baseline and Day 90
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Photographic improvement score based on standardized clinical photographs
大体时间：Baseline and Day 90
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Standardized clinical photographs obtained at Baseline and Day 90 will be independently evaluated by two blinded assessors.
Improvement will be rated using a predefined 5-point photographic improvement scale (0 = no improvement, 1 = slight improvement, 2 = moderate improvement, 3 = marked improvement, 4 = excellent improvement).
The mean photographic improvement score will be reported.
Higher scores indicate greater improvement in localized adiposity.
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Baseline and Day 90
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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