Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.

Обзор

This clinical investigation is a prospective, interventional, single-center study designed to assess the safety and effectiveness of BtH Body 2.2%, a cross-linked hyaluronic acid injectable intended for aesthetic volumization and contouring of large body areas. The study enrolls 80 adult participants who seek aesthetic improvement in the gluteal region, thighs, or abdomen. Each participant will receive a single session of subcutaneous injections, with the option for a touch-up treatment at four weeks if clinically justified, and will be followed for a total of nine months. The primary aim of the study is to determine whether BtH Body 2.2% produces a clinically relevant improvement in the treated area, assessed by the Global Aesthetic Improvement Scale (GAIS), and to evaluate the safety profile of the product by monitoring the incidence of serious adverse events throughout the study period. Secondary assessments will examine patient satisfaction, investigator-rated changes in aesthetic parameters such as volume, firmness, uniformity, elasticity, and overall appearance, as well as improvements in quality of life using validated questionnaires, including the Body Self-Esteem Scale and the Patient Global Impression of Improvement (PGI-I). Objective measurements of skin hydration, elasticity, firmness, and topography will also be obtained using specialized biometric devices. The overall goal is to generate robust clinical evidence supporting the use of BtH Body 2.2% for safe and effective body contouring and volumization.

Вмешательства

• Устройство BtH Body 2.2%
  Participants receive a single session of BtH Body 2.2%, a sterile, cross-linked hyaluronic acid hydrogel injected subcutaneously into one or more predefined body areas - gluteal region, thighs, or abdomen - to provide volumization and aesthetic contour improvement. Injections are performed using the cannulas provided with the product, following standard subcutaneous infiltration technique. An optional touch-up may be administered at the 4-week visit if the investigator considers it clinically ne

Первичные конечные точки

• Global Aesthetic Improvement Scale (GAIS) [Срок оценки: From enrollment until study completion (9 months)]
• Incidence of Serious Adverse Events (SAEs) [Срок оценки: From enrollment until study completion (9 months)]

Вторичные конечные точки (12)

• Subject Satisfaction (Likert Scale) [Срок оценки: Follow up visits: 4, 12, 24 and 36 weeks.]
• Aesthetic Parameter Scores (VAS) [Срок оценки: From enrollment until study completion (9 months)]
• Quality of Life - Body Self-Esteem Scale (SEC) [Срок оценки: From enrollment to study completion (9 months)]
• Quality of Life - Patient Global Impression of Improvement (PGI-I) [Срок оценки: From enrollment to study completion (9 months)]
• Biometric Measurements (Moisturemap) [Срок оценки: From enrollment to study completion (9 months)]
• Biometric Measurements (Corneometer) [Срок оценки: From enrollment to study completion (9 months)]
• Biometric Measurements (Cutometer) [Срок оценки: From enrollment to study completion (9 months)]
• Skin contour measurements (AEVA 3D-HE2) [Срок оценки: From enrollment to study completion (9 months)]
• Skin volume measurements (AEVA 3D-HE2) [Срок оценки: From enrollment to study completion (9 months)]
• Skin roughness measurements (AEVA 3D-HE2) [Срок оценки: From enrollment to study completion (9 months)]
• Skin surface smoothness measurements (AEVA 3D-HE2) [Срок оценки: From enrollment to study completion (9 months)]
• Volume of Product Injected [Срок оценки: From baseline to last treatment session (up to 12 weeks)]

Критерии участия

Критерии включения

• Adults (≥18 years old)
• Presence of extensive body areas (gluteal region, thighs, or abdomen) showing aesthetic concerns such as:
• loss of volume
• flaccidity
• contour asymmetries
• skin irregularities
• cellulite
• Willingness and ability to comply with all study visits and procedures.
• Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.
• Negative urine pregnancy test for women of childbearing potential at required visits.
• Use of appropriate contraception for women of childbearing potential, as outlined in the protocol.

Критерии исключения

• Allergy or sensitivity to any of the components of the investigational product.
• Planned pregnancy or breastfeeding.
• Presence of active pathology or bacterial, fungal, or viral infection in or near the area to be treated, or undergoing active treatment for these conditions
• Presence of clinical signs of inflammation in or near the area of interest or undergoing active treatment for these conditions.
• Individuals with a known tendency to develop hypertrophic scars or keloids.
• Individuals undergoing anticoagulant therapy.
• Presence of volumetric defects that are too large and require surgical procedures, in the opinion of the healthcare specialist.
• Subjects who have undergone any interventional cosmetic procedure in the 6 months prior to entering the study or during the study, such as laser, radiofrequency, electrotherapy, intradermal fillers, lipotransfer, thread lifts, platelet-rich plasma, among others.
• Subjects with disproportionate expectations regarding the expected results of treatment.
• Subjects with any of the following contraindications: Chronic conditions (Active autoimmune diseases (or under immunosuppressive treatment): Systemic lupus erythematosus, scleroderma, active rheumatoid arthritis, or Sjögren's syndrome; Active infections or inflammatory processes in the area of application: Herpes simplex, pustular acne, folliculitis, or cellulitis; Uncontrolled coagulation disorders or use of anticoagulants; Immunocompromised patients (due to disease or treatment): Uncontrolled HIV, chemotherapy, systemic corticosteroids, or organ transplantation) and medications (medications that increase the risk of bleeding or bruising: anticoagulants (warfarin or acenocoumarol) and antiplatelet agents (salicylic acid, prasugrel, or ticagrelor), immunosuppressants and biologics (prolonged systemic corticosteroids such as methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, biologic drugs such as infliximab or adalimumab), systemic retinoids (isotretinoin), antidepressants, oral antidiabetics/insulin)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Complutense Medical Center (Virtus Group) — Madrid

Идентификаторы

NCT: NCT07441135 · BtHCb-PIC01-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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