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

NCT07441135 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Aesthetic Body Volume Loss

Interventions

DEVICE

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 necessary.

Sponsors & Collaborators

  • Dr. Goya Análisis, SL.

    collaborator INDUSTRY

  • i+Med S.Coop.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441135 on ClinicalTrials.gov