Soft Tissue AugmentationPhase 4HArmonyCa EUMDNCT05119777

HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

A Phase 4 study testing HArmonyCa Injectable Gel in people with Soft Tissue Augmentation, run by Allergan at 2 sites in France.

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

Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Soft Tissue Augmentation
What is being tested?: HArmonyCa Injectable Gel
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 2 sitesFrance
Study dates: 13 Oct 2021to 15 Sep 2023
Phase: Phase 4
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 18 or older at the time of signing the ICF
In general good health
Participant seeking soft tissue augmentation in the mid face
Has moderate or severe mid face volume deficit (Grade 5, 4, or 3 on the MFVDS) for each cheek on EI (Evaluating Investigator) live assessment (both cheeks must qualify but do not need to have the same score)
Each cheek is amenable to achieving at least a 1-point improvement on the MFVDS with study intervention in the judgment of the EI (Evaluating Investigator)/TI (Treating Investigator)
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol

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Written informed consent from the participant has been obtained prior to any study-related procedures
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
Able, as assessed by the EI, and willing to follow study instructions (including compliance with the safety diary) and likely to complete all required study visits
Fluent and literate in French

Who cannot join

HArmonyCa is contraindicated:
in patients with a known sensitivity to any of the product components.
in patients suffering from skin disease or abnormal skin conditions.
in patients suffering from an infection or inflammation (either acute or chronic) at or near the treatment site.
in patients susceptible to keloid formation, hypertrophic scarring, or developing inflammatory skin conditions.
in patients with impaired wound healing due to systemic disorders, medicinal drugs, or unhealthy or poorly-vascularized tissue.

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in patients suffering from prolonged bleeding or tissue healing due to medical conditions or medicinal drugs.
in patients with a history of anaphylactic reactions and/or multiple severe allergies.
in patients with a known sensitivity to steroids, or who are contraindicated to be treated with steroids.
for injection into the glabellar or periocular areas.
for injection into the lips and perioral region.
for injection into regions containing foreign bodies.
in patients presenting with herpes.
in patients with autoimmune diseases.
for injection into blood vessels and to highly vascularized areas.
for injection into the epidermis or superficial dermis.
in breastfeeding or pregnant women.
in patients below the age of 18.
Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring
History of anaphylaxis or allergy to HA products, or Streptococcal protein
Fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face
Semi-permanent soft-tissue filler treatment (eg, CaHA, poly-L-lactic acid) in the face within 36 months before enrollment
Temporary dermal filler injections in the face within 24 months before enrollment
Botulinum toxin treatment in the cheek area (including crow's feet, depressor anguli oris, jawline, platysma, etc.) within 6 months before enrollment
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.
Changes in use of over-the-counter or prescription oral or topical, anti-wrinkle products in the face within 30 days before enrollment or planned changes during the study. Participants are not eligible for this study if they have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products in the face within 30 days before enrollment or are planning to begin using such products during the study. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study.
Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
Has received LASIK surgery or other surgical intervention on the eye within 3 months prior to enrollment or is planning such a procedure
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Has tattoos, piercings, facial hair, or scars in the face that would interfere with the visualization of the face for the effectiveness assessment
Has undergone a dental procedure within 6 weeks before treatment or plans to undergo a dental procedure (other than prophylaxis or dental fillings) during the course of the study
Females who are pregnant, planning a pregnancy, or nursing.
TI's discretion based on participant's safety and/or study integrity. The participant has a condition or is in a situation that, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
Directly or indirectly involved in the conduct and administration of this study. Directly or indirectly involved in the conduct and administration of this study as an investigator, sub-investigator, study coordinator, or other study staff member; employee of the sponsor; first degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.

Trial locations and contacts

2 sites in 1 country.

France2 sites

Eurofins Dermscan Pharmascan /ID# 240921
Aix-en-Provence, 13594
Eurofins Pharmascan /ID# 240920
Lyon, 69100

Other trials in France

About this study

Official title: Prospective, Open Label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid-face Soft Tissue Augmentation

Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

Conditions: Soft Tissue Augmentation
Being tested: HArmonyCa Injectable Gel

What participants receive

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

HArmonyCa Injectable GelDevice
Subdermal or deep dermal injection

Study groups in NCT05119777
Study group	Role	What they receive
HArmonyCa Injectable Gel	Experimental	HArmonyCa injected at the discretion of the Treating Investigator (TI) to the midface for initial treatment and an optional touch-up treatment 14 days later Receives: Device: HArmonyCa Injectable Gel

What is being measured

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

Responder status of achieving ≥ 1-grade improvement from baseline on Mid Face Volume Deficit Scale (MFVDS) based on EI's (Evaluating Investigator) live assessment at Month 1
The MFVDS is a validated, 6-point scale with grades of severe (5), significant (4), moderate (3), mild (2), minimal (1), and none (0)
Measured: 1 Month

Secondary outcomes (3)

Responder status of achieving improved or much improved on Global Aesthetic Improvement Scale (GAIS) based on EI live assessment at Month 1 visit
The GAIS is a validated, 5-point scale with grades of much improved (2), improved (1), no change (0), worse (-1), and much worse (-2)
Measured: 1 Month
Responder status of achieving improved or much improved on GAIS based on participant assessment at Month 1 visit
The GAIS is a validated, 5-point scale with grades of much improved (2), improved (1), no change (0), worse (-1), and much worse (-2)
Measured: 1 Month
Change from baseline on FACE-Q Satisfaction with Cheeks specific questionnaire at Month 1 visit
The FACE-Q is a validated 4-item Satisfaction with Cheeks questionnaire evaluated by the participant (very dissatisfied, somewhat dissatisfied, somewhat satisfied, very satisfied).
Measured: 1 Month

Timeline

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

13 Oct 202115 Sep 2023

First posted15 Nov 2021
Study start13 Oct 2021
Primary completion15 Sep 2023
Study completion15 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Soft Tissue AugmentationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05119777
Sponsor's protocol ID: M21-787
Other IDs: 2021-A01899-32
Acronym: HArmonyCa EUMD
Status last verified: Sep 2024
First submitted: 4 Nov 2021
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Sandwich vs. Mixed Bone Augmentation for Implant Placement
Peri-implant Bone and Soft Tissues
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants

All Soft Tissue Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Open Label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid-face Soft Tissue Augmentation
ClinicalTrials.gov ID: NCT05119777
Acronym / sponsor ID: HArmonyCa EUMD / M21-787
Conditions: Soft Tissue Augmentation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 13 Oct 2021 (actual)
Primary completion: 15 Sep 2023 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 15 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HArmonyCa Injectable Gel	Experimental	Device: HArmonyCa Injectable GelHArmonyCa injected at the discretion of the Treating Investigator (TI) to the midface for initial treatment and an optional touch-up treatment 14 days later

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participant must be 18 or older at the time of signing the ICF
In general good health
Participant seeking soft tissue augmentation in the mid face
Has moderate or severe mid face volume deficit (Grade 5, 4, or 3 on the MFVDS) for each cheek on EI (Evaluating Investigator) live assessment (both cheeks must qualify but do not need to have the same score)
Each cheek is amenable to achieving at least a 1-point improvement on the MFVDS with study intervention in the judgment of the EI (Evaluating Investigator)/TI (Treating Investigator)

Key exclusion criteria (34 listed)

HArmonyCa is contraindicated:
Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring
History of anaphylaxis or allergy to HA products, or Streptococcal protein
Fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face
Semi-permanent soft-tissue filler treatment (eg, CaHA, poly-L-lactic acid) in the face within 36 months before enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HArmonyCa Injectable GelSubdermal or deep dermal injection	Device	HArmonyCa Injectable Gel

Primary outcome

Responder status of achieving ≥ 1-grade improvement from baseline on Mid Face Volume Deficit Scale (MFVDS) based on EI's (Evaluating Investigator) live assessment at Month 1
Time frame: 1 Month
The MFVDS is a validated, 6-point scale with grades of severe (5), significant (4), moderate (3), mild (2), minimal (1), and none (0)

3 secondary outcomes

Responder status of achieving improved or much improved on Global Aesthetic Improvement Scale (GAIS) based on EI live assessment at Month 1 visit
Time frame: 1 Month
Responder status of achieving improved or much improved on GAIS based on participant assessment at Month 1 visit
Time frame: 1 Month
Change from baseline on FACE-Q Satisfaction with Cheeks specific questionnaire at Month 1 visit
Time frame: 1 Month

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Soft Tissue Augmentation

Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Sandwich vs. Mixed Bone Augmentation for Implant Placement
Peri-implant Bone and Soft Tissues
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ALLERGAN INC. study director

Allergan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HArmonyCa Injectable Gel in people with Soft Tissue Augmentation, run by Allergan at 2 sites in France.

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 10 inclusion and 34 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Responder status of achieving ≥ 1-grade improvement from baseline on Mid Face Volume Deficit Scale (MFVDS) based on EI's (Evaluating Investigator) live assessment at Month 1 (time frame: 1 Month). 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 NCT05119777.

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 19 Sep 2024.