New injectable gel aims to reshape buttocks, thighs, and belly without surgery

NCT ID NCT07441135

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests a gel made of hyaluronic acid, injected under the skin to add volume and improve the shape of the buttocks, thighs, or abdomen. Eighty adults who want aesthetic improvement will receive one treatment session, with an optional touch-up after four weeks. Researchers will check if the treatment improves appearance and how safe it is over nine months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyaluronic acid gel (BtH Body 2.2%)
What this could lead to
If it works, this could offer a non-surgical option to restore volume and improve body shape in areas like the buttocks, thighs, or abdomen.
What could go wrong
This is a small, early study with no comparison group. Results may not apply to everyone, and risks include injection-related side effects like swelling or bruising.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complutense Medical Center (Virtus Group)

    RECRUITING

    Madrid, Madrid, 28805, Spain