AestheticNCT07193199

New Technique and Product for Chin Enhancement

A study testing Revanesse Sculpt+ in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Aesthetic
What is being tested?: Revanesse Sculpt+
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteCanada
Study dates: 2 Jun 2025to 24 Jul 2026
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At the time of consent, male and female participants 18 years of age and older;
Participants with established chin retrusion at Baseline (a score of minimal, moderate or severe; based on the Treating Investigator's Allergan Chin Retrusion Scale(ACRS)1 assessment;
Accepted the obligation not to receive any other facial procedures throughout the study duration;
Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
No previous lower face fillers for 12 months prior to this study;
Capable of providing informed consent;
Willing to undergo scheduled CT scans as part of the study design;
Females of childbearing potential agree to take a scheduled urinary pregnancy test (UPT) prior to treatment administration.

Who cannot join

Participants without chin retrusion at Screening, per the ACRS1 ;
Participants with extreme chin retrusion at Screening as per the ACRS1;
Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
Hypersensitivity to Revanesse products, hyaluronic acid filler or amide local anesthetics;
Participants presenting with porphyria or any other liver diseases;
Inability to comply with follow-up and abstain from facial injections during the study period;

Show all 38Show fewer

Heavy smokers, classified as smoking more than 12 cigarettes per day;
History of severe or multiple allergies manifested by anaphylaxis, since drug allergies might preclude optimal management of complications;
Previous tissue revitalization therapy in the treatment area (i.e., the lower face) within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
Previous facial surgery, including liposuction;
Lifetime history of permanent implants in the treatment region (i.e., the lower face) including but not limited to dental implants;
Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the lower face);
History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
Active facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents;
Scars, deformities, piercing, or tattoos in the treatment areas;
Facial cancer or precancer (e.g., actinic keratosis);
History of radiation therapy to the treatment area;
History of bleeding disorders, or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
Participants with immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or participants using immunosuppressants;
Participants with a tendency to form hypertrophic or keloid scars, or any other healing disorders;
Participants with a tendency to form post-inflammatory hyperpigmentation;
Participants with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmic);
Participants administered dental block or topical administration of lidocaine within 2 weeks of treatment;
Participants with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction;
Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity);
Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts;
Planned vaccinations during the 2-week period before and after filler treatments;
Lifetime history of cystic acne, due to increased risk of cyst development following filler treatment;
CT scan reveals any bone-related abnormality (e.g., Osteoporosis, Paget's disease, bone infection or cancer), deformity, growths or anything in the Primary Investigator's opinion would interfere with the assessment of any endpoint;
Participant is undergoing orthodontic procedures/treatments that manipulate the teeth and underlying bone structure including but not limited to braces and Invisalign treatments;
Participants who cannot/should not, for any reason (medical or otherwise), undergo scheduled CT scans (i.e., due to increased safety risks);
History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participants participation in this study or would make the participant an unsuitable candidate to receive study medical device;
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
History of facial nerve palsy
Infection or dermatological condition at the treatment injection sites
Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin
Participant has an anticipated need for overnight hospitalization or scheduled surgery;
Participant has been treated with any other investigational product at least 30 days before the first administration of the current investigational product.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Erevna Innovations Inc.
Montreal, Quebec, H3Z 1C3

Other trials in Canada

About this study

Official title: A Novel Substrate and Injection Technique for Chin Augmentation

The use of hyaluronic acid (HA) fillers for soft tissue augmentation offers a valuable treatment modality for the correction of chin retrusion (i.e., when the chin appears to be set back or further back than normal in relation to the rest of the face). Their use is well-tolerated and provides satisfactory aesthetic results by improving facial balance and projection. Although the efficacy of hyaluronic acid HA fillers for chin augmentation has been established, the specific anatomy of the region may lead to adverse events. More specifically, certain fillers with strong integration characteristics may lead to product migration, while others with poor integration characteristics may lead to palpable deformities and distortion of the surrounding injection tissues.

Using a filler that has a high concentration of hyaluronic acid, a medium level of firmness and low water absorption may offer an effective option for treating this indication while minimizing certain adverse events. In addition, using consistent, standardized injection techniques can help achieve an ideal result.

We believe that the use of a novel HA gel (Revanesse Sculp+) for the chin, with a high concentration of HA, a moderate firmness and low water absorption, will perform better than historical controls with firmer properties in the management of chin retrusion.

Conditions: Aesthetic
Being tested: Revanesse Sculpt+
Keywords: Hyaluronic Acid, Fillers, Facial Assessment, Chin Augmentation

What participants receive

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

Revanesse Sculpt+Device
Revanesse Sculpt+ is approved and commercially available for use in Canada and is manufactured by Prollenium Technologies Inc. All study participants will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion.

Study groups in NCT07193199
Study group	Role	What they receive
Revanesse Sculpt+	Other	Twenty-one (n = 21) male and female participants aged 18 years or older, including seven (n = 7) participants within each of the Allergan Chin Retrusion Scale(ACRS) categories corresponding to mild, moderate, and severe, based on the assessment of the Treating Investigator, will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion at the Baseline visit (Visit 2) and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator. Receives: Device: Revanesse Sculpt+

What is being measured

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

Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
Frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator.
The Global Aesthetics Improvement Scale (GAIS) is a five-point Likert scale, categorized as "worse", "no change", "improved", "much improved" and "very much improved".
Measured: Baseline to Month 12
Proportion of participants with ≥1 grade-point improvement from baseline in chin retrusion, as assessed by a blinded evaluator using the CCPS and/or ACRS
The Croma Chin Projection Assessment Scale (CCPS) is a a validated 5-point assessment tool for the projection of the chin using a vertical line from pogonium through the lower vermilion boarder in front of the labiomental crease. It grades chin retrusion from 0 (ideal chin projection) to 4 (very severe retrusion).
The Allergan Chin Retrusion Scale (ACRS) is a validated 5-point assessment tool for chin retrusion using the midpoint of the chin and the lower vermillion boarder. It grades chin retrusion from 0 (no retrusion) to 4 (extreme chin retrusion).
Measured: Baseline to Month 12

Secondary outcomes (2)

Frequency of post-injection reactions including pain and discomfort during treatment, immediately after treatment, and at 14 days post-treatment
Frequency of post injection reactions including pain and discomfort (generalized, during chewing, talking, and/or kissing as applicable) during treatment, immediately after treatment and 14 days following treatment.
Measured: Baseline to Month 12
Frequency of physician-reported and participant-reported adverse events (AEs) at any visit post-injection
Frequency of post injections reactions including physician-reported and participant-reported adverse events (AEs) at any visit.
Measured: Baseline to Month 12

Timeline

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

2 Jun 202524 Jul 2026

First posted25 Sep 2025
Study start2 Jun 2025
Primary completion1 Jun 2026
Study completion24 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AestheticStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07193199
Sponsor's protocol ID: PRO-2025-RS
Status last verified: Aug 2026
First submitted: 11 Jul 2025
Last updated: 5 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

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All Aesthetic trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Novel Substrate and Injection Technique for Chin Augmentation
ClinicalTrials.gov ID: NCT07193199
Acronym / sponsor ID: PRO-2025-RS
Conditions: Aesthetic
Keywords: Hyaluronic Acid, Fillers, Facial Assessment, Chin Augmentation
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Erevna Innovations Inc.University, hospital or other
Study start: 2 Jun 2025 (actual)
Primary completion: 1 Jun 2026 (actual)
Study completion: 24 Jul 2026 (actual)
First posted: 25 Sep 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Revanesse Sculpt+	Other	Device: Revanesse Sculpt+Twenty-one (n = 21) male and female participants aged 18 years or older, including seven (n = 7) participants within each of the Allergan Chin Retrusion Scale(ACRS) categories corresponding to mild, moderate, and severe, based on the assessment of the Treating Investigator, will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion at the Baseline visit (Visit 2) and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

At the time of consent, male and female participants 18 years of age and older;
Participants with established chin retrusion at Baseline (a score of minimal, moderate or severe; based on the Treating Investigator's Allergan Chin Retrusion Scale(ACRS)1 assessment;
Accepted the obligation not to receive any other facial procedures throughout the study duration;
Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
No previous lower face fillers for 12 months prior to this study;

Key exclusion criteria (38 listed)

Participants without chin retrusion at Screening, per the ACRS1 ;
Participants with extreme chin retrusion at Screening as per the ACRS1;
Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
Hypersensitivity to Revanesse products, hyaluronic acid filler or amide local anesthetics;
Participants presenting with porphyria or any other liver diseases;

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
Revanesse Sculpt+Revanesse Sculpt+ is approved and commercially available for use in Canada and is manufactured by Prollenium Technologies Inc. All study participants will receive Revanesse Sculpt+ for the treatment of mild to severe chin retrusion.	Device	Revanesse Sculpt+

Primary outcome

Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12
Time frame: Baseline to Month 12
Frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator. The Global Aesthetics Improvement Scale (GAIS) is a five-point Likert scale, categorized as "worse", "no change", "improved", "much improved" and "very much improved".
Proportion of participants with ≥1 grade-point improvement from baseline in chin retrusion, as assessed by a blinded evaluator using the CCPS and/or ACRS
Time frame: Baseline to Month 12
The Croma Chin Projection Assessment Scale (CCPS) is a a validated 5-point assessment tool for the projection of the chin using a vertical line from pogonium through the lower vermilion boarder in front of the labiomental crease. It grades chin retrusion from 0 (ideal chin projection) to 4 (very severe retrusion). The Allergan Chin Retrusion Scale (ACRS) is a validated 5-point assessment tool for chin retrusion using the midpoint of the chin and the lower vermillion boarder. It grades chin retrusion from 0 (no retrusion) to 4 (extreme chin retrusion).

2 secondary outcomes

Frequency of post-injection reactions including pain and discomfort during treatment, immediately after treatment, and at 14 days post-treatment
Time frame: Baseline to Month 12
Frequency of physician-reported and participant-reported adverse events (AEs) at any visit post-injection
Time frame: Baseline to Month 12

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 5 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Aesthetic

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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
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Not yet recruiting
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Peri-Implantitis
Enrolling by invitation
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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.

Andreas Nikolis, MD, PhD principal investigator

Erevna Innovations Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Revanesse Sculpt+ in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.

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 8 inclusion and 38 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

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?

Frequency of participants graded as at least 'improved' on the Global Aesthetic Improvement Scale (GAIS) by a blinded evaluator at baseline to Month 12 (time frame: Baseline to Month 12). 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 NCT07193199.

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 5 Aug 2026.