Efficacy, Satisfaction, and Safety of the Mesolipo® Protocol for the Treatment of Localized Adiposity

NCT07743788 | Completed

• 1 other identifier: 83014024.2.1001.5128
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Adiposity

Keywords

Efficacy; Safety; Sodium Deoxycholate; Localized Adiposity; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• Treatment efficacy

  Assessed by the reduction in skinfold thickness measured using standardized skinfold calipers.

  Baseline to Day 90

• Treatment Safety

  Safety will be assessed by the occurrence, frequency, and severity of treatment-related adverse events.

  Baseline to day 90

Secondary Outcomes (3)

• 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

Study Arms (2)

Mesolipo® Protocol

EXPERIMENTAL

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.

Drug: Mesolipo®

Active Comparator

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.

Drug: Pentoxifylline

Interventions

Mesolipo® DRUG

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.

Mesolipo® Protocol

Pentoxifylline DRUG

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.

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antony de Paula Barbosa: lead

Study Sites (1)

Instituto Antony Barbosa

Belo Horizonte, Minas Gerais, 30493-240, Brazil

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Antony Barbosa Institute

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 4, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)