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New filler gel aims to restore youthful cheeks

NCT ID NCT05452070

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an injectable gel called HArmonyCa lidocaine for filling out the mid face area in adults. About 171 participants were split into two groups: one received the gel right away, the other waited 3 months. Researchers checked for side effects and how well the gel improved cheek volume over up to 25 months.

What this could mean

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

Active substance
HArmonyCa lidocaine injectable gel (dermal filler)
What this could lead to
If it works, this could offer a safe and effective option for restoring mid face volume loss due to aging.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. As with any filler, risks include swelling, bruising, or uneven results.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

171 people

The number who actually took part.

Started

Sep 2022

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

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: * Participant must be in general good health. * Participant seeking soft tissue augmentation in the mid face. * Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. * Able, as assessed by the TI, and willing to follow study instructions (including compliance with the safety e-diary) and likely to complete all required study visits. Exclusion Criteria: * Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring * Has active or recurrent inflammation or infection in either eye * Has tendency to develop hypertrophic scarring and/or keloid scarring * Has active autoimmune disease * Has current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, in the face * Has fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face * Has temporary dermal filler injections in the face within 24 months before enrollment * Has semi-permanent fillers (eg, poly-L-lactic acid, CaHA) anywhere in the face within 36 months before enrollment * Has botulinum toxin treatment in cheek area (including crow's feet) within 6 months before enrollment * Has mesotherapy or cosmetic facial procedures in the face within 6 months before enrollment. Examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures * Has tattoos, piercings, facial hair, (unless willing to remove prior to each assessment visit) or scars in the face that would interfere with the visualization of the face for the effectiveness assessment * Undergone a dental procedure within 6 weeks before treatment or plan to undergo a dental procedure (other than prophylaxis or dental fillings) during the course of the study * History of an allergic reaction or significant sensitivity to constituents of the study investigational product (and its excipients) and/or other products in the same class (lidocaine \[or any amide-based anesthetics\], HA products, or Streptococcal protein). * Any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study. * Any live vaccine within 4 weeks prior to the first dose of study treatment, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study treatment.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Bertucci MedSpa Inc. /ID# 246496

    Woodbridge, Ontario, L4L 8E2, Canada

  • Dermetics Cosmetic Dermatology /ID# 246536

    Burlington, Ontario, L7N 3N2, Canada

  • Dr Nestor's Medical Cosmetic Centre /ID# 246406

    Edinburgh, EH3 6RS, United Kingdom

  • Erevna Innovations Inc. /ID# 240401

    Westmount, Quebec, H3C 1Z3, Canada

  • Humphrey & Beleznay Cosmetic Dermatology /ID# 239805

    Vancouver, British Columbia, V5Z 4E1, Canada

  • Instituto Medico Miramar /ID# 240939

    Málaga, Malaga, 29016, Spain

  • MediZen /ID# 240102

    Sutton Coldfield, B74 2UG, United Kingdom

  • Pacific Derm /ID# 240785

    Vancouver, British Columbia, V6H 4E1, Canada

  • Skin Matters Medical Aesthetic Centre /ID# 239986

    Vancouver, British Columbia, V6M 4J2, Canada

  • The Centre for Clinical Trials /ID# 246409

    Oakville, Ontario, L6J 7W5, Canada

  • WM Hospitals /ID# 245747

    Barcelona, 08006, Spain

  • YVR Aesthetics Training & Study Centre /ID# 239809

    Vancouver, British Columbia, V5Z 1H2, Canada

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