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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazylia, 30493-240
- Instituto Antony Barbosa
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Treatment efficacy
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient satisfaction score assessed using a 5-point Likert satisfaction scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 83014024.2.1001.5128
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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