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

February 25, 2026 updated by: i+Med S.Coop.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BtH Body 2.2% Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS)
Time Frame: 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.
From enrollment until study completion (9 months)
Incidence of Serious Adverse Events (SAEs)
Time Frame: From enrollment until study completion (9 months)
Frequency of serious adverse events occurring at any point during the study.
From enrollment until study completion (9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Satisfaction (Likert Scale)
Time Frame: Follow up visits: 4, 12, 24 and 36 weeks.
Participant-reported satisfaction (5-point scale): very satisfied, satisfied, slightly satisfied, indifferent and dissatisfied, this scale will be recorded at follow-up visits.
Follow up visits: 4, 12, 24 and 36 weeks.
Aesthetic Parameter Scores (VAS)
Time Frame: From enrollment until study completion (9 months)
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.
From enrollment until study completion (9 months)
Quality of Life - Body Self-Esteem Scale (SEC)
Time Frame: From enrollment to study completion (9 months)
Change from baseline in the Body Self-Esteem Scale (1-10 points), 1 being no satisfaction and 10 being very satisfied.
From enrollment to study completion (9 months)
Quality of Life - Patient Global Impression of Improvement (PGI-I)
Time Frame: From enrollment to study completion (9 months)
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).
From enrollment to study completion (9 months)
Biometric Measurements (Moisturemap)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Biometric Measurements (Corneometer)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Biometric Measurements (Cutometer)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Skin contour measurements (AEVA 3D-HE2)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Skin volume measurements (AEVA 3D-HE2)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Skin roughness measurements (AEVA 3D-HE2)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Skin surface smoothness measurements (AEVA 3D-HE2)
Time Frame: From enrollment to study completion (9 months)
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.
From enrollment to study completion (9 months)
Volume of Product Injected
Time Frame: From baseline to last treatment session (up to 12 weeks)
Total amount of BtH Body 2.2% administered per participant, including touch-up session if performed.
From baseline to last treatment session (up to 12 weeks)
Future-Use Questionnaire (Participant)
Time Frame: Week 36 (end of study)
Participant expectations and willingness to repeat or recommend the treatment. Assessed at V5.
Week 36 (end of study)
Usability Questionnaire (Investigator)
Time Frame: Week 36 (end of study)
Investigator-reported usability of the product (at V5).
Week 36 (end of study)
Incidence of Non-Serious Adverse Events (AEs)
Time Frame: From enrollment to study completion (9 months)
Frequency, severity, and characteristics of non-serious events throughout the study.
From enrollment to study completion (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i+Med S.Coop.

Collaborators

Dr. Goya Análisis, SL.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BtHCb-PIC01-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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