Eficácia,Satisfação e Segurança do Protocolo Mesolipo® no Tratamento da Gordura Localizada: um Estudo Randomizado
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
This randomized, split-body clinical trial aims to evaluate the efficacy, safety, and participant satisfaction of the Mesolipo® protocol for the treatment of localized adiposity. Participants will receive the Mesolipo® intervention on one side of the body and an active comparator on the contralateral side. Outcomes will be assessed through standardized clinical, photographic, ultrasonographic, and patient-reported measures over a 90-day follow-up period to determine treatment effectiveness and safety.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to the intervention assigned to each side of the body. The professional responsible for preparing or administering the interventions will not be blinded. Treatment allocation will be coded, and clinical photographs and outcome measurements will be evaluated without identification of the intervention received on each side.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment efficacy
时间窗: Baseline to Day 90
Assessed by the reduction in skinfold thickness measured using standardized skinfold calipers.
Treatment Safety
时间窗: Baseline to day 90
Safety will be assessed by the occurrence, frequency, and severity of treatment-related adverse events.
次要结局
- Patient satisfaction score assessed using a 5-point Likert satisfaction scale(Day 90)
- Global Aesthetic Improvement Scale (GAIS) score(Baseline and Day 90)
- Photographic improvement score based on standardized clinical photographs(Baseline and Day 90)
研究者
Antony de Paula Barbosa
Director, Antony Barbosa Institute
Antony Barbosa Institute