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Filler combo aims to restore cheek volume after weight loss

NCT ID NCT06351358

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether combining two types of dermal fillers—Sculptra and Restylane—can improve cheek volume, wrinkles, and skin quality in 41 adults with moderate-to-severe cheek aging. Participants had a history of weight loss or were taking GLP-1 medications. They received up to three Sculptra sessions and one or two Restylane injections over 8 weeks. The study measured changes in skin hydration, radiance, elasticity, and thickness, and asked participants about their satisfaction.

What this could mean

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

Active substance
Sculptra (poly-L-lactic acid) and Restylane (hyaluronic acid) dermal fillers
What this could lead to
If successful, this combination approach could offer a more effective, longer-lasting option for restoring cheek volume and skin quality in people with midface aging or post-weight-loss changes.
What could go wrong
This was a small, completed study with no control group, so results may not apply broadly. Dermal fillers carry risks like swelling, bruising, or lumpiness, and effects are temporary.

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

41 people

The number who actually took part.

Started

Feb 2024

Finished

May 2025

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

22 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site * Any races and ethnicities, with effort to include minimum n = 2 per site for whom identify as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Hispanic or Latino, Black or African American, Native Hawaiian or Other Pacific Islander, etc. * Subject with moderate-to-severe cheek wrinkles on the GCWS * Subject with mild-to-severe midface contour deficiencies on the MMVS * Subject with intent to undergo correction of cheek augmentation or midface contour deficiencies. * Subject with history of taking or currently taking GLP-1 receptor agonist medications such as semaglutide, liraglutide, etc. * Subject with stable Body Mass Index (BMI) within 4-6 weeks before study start. * Subject willing to maintain a stable Body Mass Index (BMI, ± 2 kg/m2) throughout the study. * Willing to maintain the current lifestyle and daily routine (e.g., diet, exercise, sleep, etc.) throughout the study. * Subject willing to be photographed at each visit. * Subject willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study. * For female subjects of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatments. (Females of non-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy, are not required to have a UPT.) * Male subjects must be willing to shave prior to each study visit. * Ability to read, understand and give consent for participation in the study. * Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments. Exclusion Criteria: * Pregnant, breastfeeding, or planning pregnancy during the course of the study. * Current smokers or consumer of nicotine. * History of allergy or hypersensitivity to any ingredient of the treatment products, anesthetics or lidocaine * Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions * Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except the lips * History of injectable polymethylmethacrylate (PMMA) treatment * Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures in the treatment area at any time during the study * Presence of any disease or lesions near or on the area to be treated * History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation. * Previous surgery, including plastic surgery, lifting threads, tissue grafting, or tissue augmentation with permanent implants, silicone, tattoo affecting the treatment area, or any procedure, at the discretion of the Investigator, would interfere with the outcome of the study. * Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion * Other condition preventing the subject from entering the study in the Investigator's opinion * Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company. * Participation in any interventional clinical study within 30 days of screening.

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Conditions

The condition(s) this trial relates to.

cutis laxa Weight Loss

As listed by the trial registrant

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

Contacts and locations

Locations

  • Lorenc Aesthetic Plastic Surgery Center

    New York, New York, 10028, United States

  • Somenek + Pittman MD: Advanced Plastic Surgery

    Washington D.C., District of Columbia, 20037, United States

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