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.
Adults (≥18 years old)
loss of volume
flaccidity
contour asymmetries
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.
Single group
BtH Body 2.2%
DeviceParticipants 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 necessary.
Global Aesthetic Improvement Scale (GAIS)
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)
Frequency of serious adverse events occurring at any point during the study.
Subject Satisfaction (Likert Scale)
Participant-reported satisfaction (5-point scale): very satisfied, satisfied, slightly satisfied, indifferent and dissatisfied, this scale will be recorded at follow-up visits.
Aesthetic Parameter Scores (VAS)
Investigator-rated evaluation (VAS from 0 to 10) of volume, symmetry, shape, firmness, uniformity, hydration, elasticity, tonicity, and general appearance. Improvement from baseline is calculated.
Quality of Life - Body Self-Esteem Scale (SEC)
Change from baseline in the Body Self-Esteem Scale (1-10 points), 1 being no satisfaction and 10 being very satisfied.
Quality of Life - Patient Global Impression of Improvement (PGI-I)
Participant-reported impression of improvement (1-7 scale). Responders are considered those reporting "a little better"(3), "much better"(2), or "very much better"(1).
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i+Med S.Coop.
Lead sponsor
Dr. Goya Análisis, SL.
Collaborator
