BtH Body 2.2% for shaping and plumping large body areas
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.
Run by i+Med S.Coop. · NCT07441135 · Data updated 2026-11-12
This study tests BtH Body 2.2% injections to see if it safely improves volume and contour in the glutes, thighs, or abdomen for adults seeking aesthetic enhancement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | i+Med S.Coop. Industry-sponsored |
| Drugs / interventions | infliximab, adalimumab, chemotherapy, methotrexate |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07441135 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with substantial volume loss or contour concerns in the gluteal region, thighs, or abdomen who are willing to comply with study visits and procedures.
✕Probably not a fit
Individuals without a measurable aesthetic improvement in GAIS or who experience adverse events that limit benefits may not receive a noticeable improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, interventional, single-center study enrolling 80 adults who want aesthetic improvements in large Body areas such as the gluteal region, thighs, or abdomen. Participants will receive a single subcutaneous injection session of BtH Body 2.2%, with a possible touch-up at four weeks if clinically justified, and will be followed for nine months. The primary goal is to determine clinically meaningful improvement using the Global Aesthetic Improvement Scale (GAIS) and to monitor safety by tracking serious adverse events. Secondary assessments include patient satisfaction and investigator-rated changes in appearance. The study is conducted at a single center in Madrid, led by i+Med S.Coop. with collaboration from Dr. Goya Análisis, SL.
Why it matters
Potential benefit: Participants may achieve improved fullness and contour in large body areas, potentially leading to greater satisfaction with appearance.
How similar studies have gone: Previous work with hyaluronic acid fillers for body contouring and volume has shown potential benefits, but results can vary by area and product formulation, making this investigation an important evaluation in a large-area indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Complutense Medical Center (Virtus Group)
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Josune Torrecilla
- Email: jtorrecilla@imasmed.com
- Phone: +34945561134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.