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Tests treatment safety and results for Aesthetic Body Volume Loss
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
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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.
- people who have undergone any treatment 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...
- people with disproportionate expectations regarding the expected results of treatment.
- people with any of the following contraindications: Chronic conditions (Active autoimmune diseases (or under immunosuppressive treatment): Systemic lupus erythematosus, scleroderma, active rheumatoid arthritis, or...
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.