Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Global Aesthetic Improvement Scale (GAIS)
时间窗: From enrollment until study completion (9 months)
Investigator-rated overall aesthetic improvement of the treated area (5-point Likert scale). Improvement (scores from 3 to 5) in ≥60% of participants at V5 or V6 is considered clinically relevant.
Incidence of Serious Adverse Events (SAEs)
时间窗: From enrollment until study completion (9 months)
Frequency of serious adverse events occurring at any point during the study.
次要结局
- Subject Satisfaction (Likert Scale)(Follow up visits: 4, 12, 24 and 36 weeks.)
- Aesthetic Parameter Scores (VAS)(From enrollment until study completion (9 months))
- Quality of Life - Body Self-Esteem Scale (SEC)(From enrollment to study completion (9 months))
- Quality of Life - Patient Global Impression of Improvement (PGI-I)(From enrollment to study completion (9 months))
- Biometric Measurements (Moisturemap)(From enrollment to study completion (9 months))
- Biometric Measurements (Corneometer)(From enrollment to study completion (9 months))
- Biometric Measurements (Cutometer)(From enrollment to study completion (9 months))
- Skin contour measurements (AEVA 3D-HE2)(From enrollment to study completion (9 months))
- Skin volume measurements (AEVA 3D-HE2)(From enrollment to study completion (9 months))
- Skin roughness measurements (AEVA 3D-HE2)(From enrollment to study completion (9 months))
- Skin surface smoothness measurements (AEVA 3D-HE2)(From enrollment to study completion (9 months))
- Volume of Product Injected(From baseline to last treatment session (up to 12 weeks))
- Future-Use Questionnaire (Participant)(Week 36 (end of study))
- Usability Questionnaire (Investigator)(Week 36 (end of study))
- Incidence of Non-Serious Adverse Events (AEs)(From enrollment to study completion (9 months))