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

N/ANot Yet RecruitingNCT07441135

i+Med S.Coop.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aesthetic Body Volume Loss

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Outcomes

Primary Outcomes

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.

Time frame: From enrollment until study completion (9 months)

Incidence of Serious Adverse Events (SAEs)

Frequency of serious adverse events occurring at any point during the study.

Time frame: From enrollment until study completion (9 months)

Secondary Outcomes

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.

Time frame: Follow up visits: 4, 12, 24 and 36 weeks.

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.

Time frame: From enrollment until study completion (9 months)

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.

Time frame: From enrollment to study completion (9 months)

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).

Time frame: From enrollment to study completion (9 months)

Biometric Measurements (Moisturemap)

Objective skin and tissue changes will be evaluated with MoistureMap which measures hydration by assessing water content in the stratum corneum and will quantify improvements in skin moisture levels.

Time frame: From enrollment to study completion (9 months)

Biometric Measurements (Corneometer)

Objective skin and tissue changes will be evaluated with Corneometer which measures hydration by assessing water content in the stratum corneum and will quantify improvements in skin hydration levels.

Time frame: From enrollment to study completion (9 months)

Biometric Measurements (Cutometer)

Objective skin and tissue changes will be evaluated with Cutometer, a suction-based device that evaluates biomechanical properties, will measure firmness and elasticity of the treated area.

Time frame: From enrollment to study completion (9 months)

Skin contour measurements (AEVA 3D-HE2)

Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin contour by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.

Time frame: From enrollment to study completion (9 months)

Skin volume measurements (AEVA 3D-HE2)

Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin volume by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.

Time frame: From enrollment to study completion (9 months)

Skin roughness measurements (AEVA 3D-HE2)

Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin roughness by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.

Time frame: From enrollment to study completion (9 months)

Skin surface smoothness measurements (AEVA 3D-HE2)

Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin surface smoothness by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.

Time frame: From enrollment to study completion (9 months)

Volume of Product Injected

Total amount of BtH Body 2.2% administered per participant, including touch-up session if performed.

Time frame: From baseline to last treatment session (up to 12 weeks)

Future-Use Questionnaire (Participant)

Participant expectations and willingness to repeat or recommend the treatment. Assessed at V5.

Time frame: Week 36 (end of study)

Usability Questionnaire (Investigator)

Investigator-reported usability of the product (at V5).

Time frame: Week 36 (end of study)

Incidence of Non-Serious Adverse Events (AEs)

Frequency, severity, and characteristics of non-serious events throughout the study.

Time frame: From enrollment to study completion (9 months)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts