New filler gel aims to restore youthful cheeks
NCT ID NCT05452070
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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171 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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May 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bertucci MedSpa Inc. /ID# 246496
Woodbridge, Ontario, L4L 8E2, Canada
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Dermetics Cosmetic Dermatology /ID# 246536
Burlington, Ontario, L7N 3N2, Canada
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Dr Nestor's Medical Cosmetic Centre /ID# 246406
Edinburgh, EH3 6RS, United Kingdom
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Erevna Innovations Inc. /ID# 240401
Westmount, Quebec, H3C 1Z3, Canada
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Humphrey & Beleznay Cosmetic Dermatology /ID# 239805
Vancouver, British Columbia, V5Z 4E1, Canada
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Instituto Medico Miramar /ID# 240939
Málaga, Malaga, 29016, Spain
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MediZen /ID# 240102
Sutton Coldfield, B74 2UG, United Kingdom
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Pacific Derm /ID# 240785
Vancouver, British Columbia, V6H 4E1, Canada
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Skin Matters Medical Aesthetic Centre /ID# 239986
Vancouver, British Columbia, V6M 4J2, Canada
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The Centre for Clinical Trials /ID# 246409
Oakville, Ontario, L6J 7W5, Canada
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WM Hospitals /ID# 245747
Barcelona, 08006, Spain
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YVR Aesthetics Training & Study Centre /ID# 239809
Vancouver, British Columbia, V5Z 1H2, Canada
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