Aesthetic Body Volume LossNCT07441135
Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.
A study testing BtH Body 2.2% in people with Aesthetic Body Volume Loss, run by i+Med S.Coop. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aesthetic Body Volume Loss
- What is being tested?
- BtH Body 2.2%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Complutense Medical Center (Virtus Group)
Madrid, Madrid, 28805
Montse Ortega, +34 621 125 099, mortega@laboratoriogoya.com
About this study
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
- Being tested
- BtH Body 2.2%
- Keywords
- Hyaluronic Acid, Body Contouring, Soft-Tissue Augmentation, Aesthetic Enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BtH Body 2.2%Device
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.
| Study group | Role | What they receive |
|---|---|---|
| BtH Body 2.2% Treatment | Experimental | 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. Receives: Device: BtH Body 2.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment until study completion (9 months)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 36 (end of study)
Usability Questionnaire (Investigator)
Investigator-reported usability of the product (at V5).
Measured: Week 36 (end of study)
Incidence of Non-Serious Adverse Events (AEs)
Frequency, severity, and characteristics of non-serious events throughout the study.
Measured: From enrollment to study completion (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic Body Volume LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441135
- Sponsor's protocol ID
- BtHCb-PIC01-2025
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.
- ClinicalTrials.gov ID
- NCT07441135
- Acronym / sponsor ID
- BtHCb-PIC01-2025
- Conditions
- Aesthetic Body Volume Loss
- Keywords
- Hyaluronic Acid, Body Contouring, Soft-Tissue Augmentation, Aesthetic Enhancement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BtH Body 2.2% Treatment | Experimental | Device: BtH Body 2.2%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | BtH Body 2.2% Treatment |
Primary outcome
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.
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.
15 secondary outcomes
Subject Satisfaction (Likert Scale)
Time frame: Follow up visits: 4, 12, 24 and 36 weeks.
Aesthetic Parameter Scores (VAS)
Time frame: From enrollment until study completion (9 months)
Quality of Life - Body Self-Esteem Scale (SEC)
Time frame: 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)
Biometric Measurements (Moisturemap)
Time frame: From enrollment to study completion (9 months)
Biometric Measurements (Corneometer)
Time frame: From enrollment to study completion (9 months)
Biometric Measurements (Cutometer)
Time frame: From enrollment to study completion (9 months)
Skin contour measurements (AEVA 3D-HE2)
Time frame: From enrollment to study completion (9 months)
Skin volume measurements (AEVA 3D-HE2)
Time frame: From enrollment to study completion (9 months)
Skin roughness measurements (AEVA 3D-HE2)
Time frame: From enrollment to study completion (9 months)
Skin surface smoothness measurements (AEVA 3D-HE2)
Time frame: From enrollment to study completion (9 months)
Volume of Product Injected
Time frame: From baseline to last treatment session (up to 12 weeks)
Future-Use Questionnaire (Participant)
Time frame: Week 36 (end of study)
Usability Questionnaire (Investigator)
Time frame: Week 36 (end of study)
Incidence of Non-Serious Adverse Events (AEs)
Time frame: From enrollment to study completion (9 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BtH Body 2.2% in people with Aesthetic Body Volume Loss, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josune Torrecilla (+34945561134, jtorrecilla@imasmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) (time frame: From enrollment until study completion (9 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.