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| Name | Class |
|---|---|
| Dr. Goya Análisis, SL. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment until study completion (9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Follow up visits: 4, 12, 24 and 36 weeks. |
| Aesthetic Parameter Scores (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josune Torrecilla | Contact | +34945561134 | jtorrecilla@imasmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense Medical Center (Virtus Group) | Recruiting | Madrid | Madrid | 28805 | Spain |
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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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | Participant expectations and willingness to repeat or recommend the treatment. Assessed at V5. | Week 36 (end of study) |
| Usability Questionnaire (Investigator) | Investigator-reported usability of the product (at V5). | Week 36 (end of study) |
| Incidence of Non-Serious Adverse Events (AEs) | Frequency, severity, and characteristics of non-serious events throughout the study. | From enrollment to study completion (9 months) |