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Mid Face Volume DeficitPhase 3NCT05452070

A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation in Adult Participants

A Phase 3 study testing HArmonyCa Lidocaine Injectable Gel in people with Mid Face Volume Deficit, run by Allergan at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mid Face Volume Deficit
What is being tested?
HArmonyCa Lidocaine Injectable Gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
12 sitesin 3 countries
Study dates
2 Sep 2022to 8 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Canada8 sites

  • Dermetics Cosmetic Dermatology /ID# 246536

    Burlington, Ontario, L7N 3N2

  • The Centre for Clinical Trials /ID# 246409

    Oakville, Ontario, L6J 7W5

  • YVR Aesthetics Training & Study Centre /ID# 239809

    Vancouver, British Columbia, V5Z 1H2

  • Humphrey & Beleznay Cosmetic Dermatology /ID# 239805

    Vancouver, British Columbia, V5Z 4E1

  • Pacific Derm /ID# 240785

    Vancouver, British Columbia, V6H 4E1

  • Skin Matters Medical Aesthetic Centre /ID# 239986

    Vancouver, British Columbia, V6M 4J2

  • Erevna Innovations Inc. /ID# 240401

    Westmount, Quebec, H3C 1Z3

  • Bertucci MedSpa Inc. /ID# 246496

    Woodbridge, Ontario, L4L 8E2

Other trials in Canada

Spain2 sites

  • WM Hospitals /ID# 245747

    Barcelona, 08006

  • Instituto Medico Miramar /ID# 240939

    Málaga, Malaga, 29016

Other trials in Spain

United Kingdom2 sites

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

    Edinburgh, EH3 6RS

  • MediZen /ID# 240102

    Sutton Coldfield, B74 2UG

Other trials in United Kingdom

About this study

Official title: An International, Multicenter, Evaluator-blinded, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation

The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel in adults seeking mid face soft tissue augmentation.

HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 160 adult participants seeking soft tissue augmentation will be enrolled in the study at approximately 15 sites worldwide.

Read more

Participants in the treatment group will receive HArmonyCa Lidocaine injectable gel at Day 1 and followed for up to 25 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period. Participants in the control group are followed for 3 months and then can opt to receive HArmonyCa Lidocaine Injectable Gel at the end of month 3. The control group will participate in the study for up to 25 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Being tested
HArmonyCa Lidocaine Injectable Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HArmonyCa Lidocaine Injectable GelDevice

    Subdermal or deep dermal injection

Study groups in NCT05452070
Study groupRoleWhat they receive
HArmonyCa Lidocaine Injectable GelExperimentalParticipants will receive HArmonyCa Lidocaine Injectable Gel on Day 1 and followed for up to 25 months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period.
Receives: Device: HArmonyCa Lidocaine Injectable Gel
Control GroupOtherParticipants will be followed for 3 months. Participants can opt to receive HArmonyCa Lidocaine Injectable Gel after 3 months and followed for up to 25 months.
Receives: Device: HArmonyCa Lidocaine Injectable Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of Mid Face Volume Deficit Scale (MFVDS)

    A "responder" is a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).

    Measured: Month 3

  2. Number of Participants with Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

    Measured: Up to 25 Months

Secondary outcomes (5)

  1. Percentage of Participants Achieving "Responder" Status for EI's Live Assessment of Global Aesthetic Improvement Scale (GAIS).

    A "responder" is a participant who achieves improved or much improved on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).

    Measured: Month 3

  2. Percentage of Participants Achieving "Responder" Status for Participant Assessment of Global Aesthetic Improvement Scale (GAIS).

    A "responder" is a participant who achieves improved or much improved on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).

    Measured: Month 3

  3. Change from baseline on overall score in FACE-Q Satisfaction with cheeks specific questionnaire

    In the FACE-Q Satisfaction with Cheeks questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.

    Measured: Month 3

  4. Change from baseline on overall score in FACE-Q Satisfaction with lower face and jawline specific questionnaire

    In the FACE-Q Satisfaction with lower face and jawline specific questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.

    Measured: Month 3

  5. Change from baseline on overall score in FACE-Q Satisfaction with appearance specific questionnaire

    In the FACE-Q Satisfaction with appearance specific questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start2 Sep 2022
  3. Primary completion8 May 2025
  4. Study completion8 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452070
Sponsor's protocol ID
M21-784
Status last verified
May 2026
First submitted
6 Jul 2022
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HArmonyCa Lidocaine Injectable Gel in people with Mid Face Volume Deficit, run by Allergan at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of Mid Face Volume Deficit Scale (MFVDS) (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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