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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazílie, 30493-240
- Instituto Antony Barbosa
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Treatment efficacy
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patient satisfaction score assessed using a 5-point Likert satisfaction scale
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 83014024.2.1001.5128
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