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

i+Med S.Coop.

Status: Not yet enrolling

Conditions: Aesthetic Body Volume Loss

Treatments: Device: BtH Body 2.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07441135

BtHCb-PIC01-2025

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

BtH Body 2.2% Treatment

Experimental group

Description:

Participants receive a single session of BtH Body 2.2%, a cross-linked hyaluronic acid injectable gel, administered subcutaneously to one or more large body areas (gluteal region, thighs, or abdomen). A touch-up session may be performed at the 4-week visit if clinically indicated. All participants are followed for 9 months with visits at 1, 3, 6, and 9 months post-treatment.

Treatment:

Device: BtH Body 2.2%