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Can a new filler give lips a lasting boost?

NCT ID NCT05773066

Disease control Sponsor: Merz North America, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial is testing whether a new dermal filler called Belotero Intense Lidocaine can safely and effectively add volume to thin lips. About 220 people who want lip augmentation will receive either this filler or a comparison filler, Restylane Silk. Researchers will measure improvements in lip fullness and overall aesthetic appearance over several weeks.

What this could mean

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

Active substance
Belotero Intense Lidocaine, a dermal hyaluronic acid filler
What this could lead to
If successful, this could offer a safe and effective option for lip augmentation, potentially providing longer-lasting or more satisfying results compared to existing fillers.
What could go wrong
As with any cosmetic filler, there are risks like swelling, bruising, or uneven results. The trial is relatively small and early, so outcomes may not apply to everyone.

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

220 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2024

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

21 to 65 years

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: * Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit Exclusion Criteria: * Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face * Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face * Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose * Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face * Has undergone oral surgery in the past 30 days * Lip volume deficit due to medical conditions * Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components

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As listed by the trial registrant

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

Lip augmentation

Contacts and locations

Locations

  • Merz Investigation Site #0010097

    Nashville, Tennessee, 37215, United States

  • Merz Investigation Site #0010101

    Coral Gables, Florida, 33146, United States

  • Merz Investigation Site #0010170

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

  • Merz Investigation Site #0010299

    Santa Monica, California, 90404, United States

  • Merz Investigation Site #0010322

    Austin, Texas, 78746, United States

  • Merz Investigation Site #0010358

    Vista, California, 92083, United States

  • Merz Investigation Site #0010436

    San Juan, 00917, Puerto Rico

  • Merz Investigation Site #0010446

    Atlanta, Georgia, 30342, United States

  • Merz Investigation Site #0010463

    Redondo Beach, California, 90277, United States

  • Merz Investigation Site #0010464

    Alpharetta, Georgia, 30005, United States

  • Merz Investigation Site #0010466

    Chicago, Illinois, 60654, United States

  • Merz Investigation Site #0010467

    Austin, Texas, 78746, United States

  • Merz Investigation Site #0010468

    Ardmore, Pennsylvania, 19003, United States

  • Merz Investigation Site #0010472

    Purchase, New York, 10577, United States

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