Localized Adiposity
Conditions
Keywords
Efficacy, Safety, Sodium Deoxycholate, Localized Adiposity, Patient Satisfaction
Brief summary
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.
Detailed description
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.
Interventions
DRUGMesolipo®
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.
DRUGPentoxifylline
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.
Sponsors
Antony de Paula Barbosa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized split-body study in which each participant will receive the Mesolipo® protocol on one side of the body and the comparator intervention on the contralateral side. Both interventions will be administered during the same study period, allowing each participant to serve as their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | Baseline to Day 90 | Assessed by the reduction in skinfold thickness measured using standardized skinfold calipers. |
| Treatment Safety | Baseline to day 90 | Safety will be assessed by the occurrence, frequency, and severity of treatment-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score assessed using a 5-point Likert satisfaction scale | Day 90 | 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. |
| Global Aesthetic Improvement Scale (GAIS) score | Baseline and Day 90 | 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. |
| Photographic improvement score based on standardized clinical photographs | Baseline and Day 90 | 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. |
Countries
Brazil
Outcome results
None listed