Chin RetrusionNCT06336772
Restylane Shaype Versus Juvederm Volux for Chin Augmentation
A study testing Restylane Shaype and Juvéderm Volux in people with Chin Retrusion, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chin Retrusion
- What is being tested?
- Restylane Shaype and Juvéderm Volux
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2023to 9 Nov 2024
- 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 subjects 18 years of age and older.
- Patients with established chin retrusion at Baseline (a score of mild, moderate, and severe severity on the Galderma Chin Retrusion Scale).
- 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.
Who cannot join
- Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
- 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 Restylane or Juvéderm products, hyaluronic acid filler or amide local anesthetics.
- Patients presenting with porphyria or any other liver diseases.
- Inability to comply with follow-up and abstain from facial injections during the study period.
- Heavy smokers, classified as smoking more than 12 cigarettes per day.
Show all 27Show fewer
- 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)
- 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, piercings, or tattoos in the treatment areas.
- Facial cancer or precancer (e.g., actinic keratosis).
- History of radiation therapy in 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.
- Patients with immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or subjects using immunosuppressants.
- Patients with a tendency to form hypertrophic or keloid scars, or any other healing disorders.
- Patients with a tendency to form post-inflammatory hyperpigmentation.
- Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics).
- Patients administered dental block or topical administration of lidocaine within 2 weeks of treatment.
- Patients 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 COVID-19 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Trial Evaluating Restylane Shaype Versus Juvederm Volux for Chin Augmentation
This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
- Conditions
- Chin Retrusion
- Being tested
- Restylane Shaype, Juvéderm Volux
- Keywords
- Chin Augmentation, Hyaluronic Acid Filler, Aesthetic Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane ShaypeDevice
Half (50%) of study participants will receive Restylane Shaype for the treatment of mild to severe chin retrusion
Juvéderm VoluxDevice
Half (50%) of study participants will receive Juvéderm Volux for the treatment of mild to severe chin retrusion
| Study group | Role | What they receive |
|---|---|---|
| Restylane Shaype | Experimental | Restylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group.
The participant will be treated at the Baseline visit 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: Restylane Shaype |
| Juvederm Volux | Active comparator | Juvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company.
The participant will be treated at the Baseline visit 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: Juvéderm Volux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant group differences in the average three-dimensional volumetric increase since baseline
As assessed by the Canfield Vectra XT system.
Measured: Baseline to Week 2, Week 4, Week 12, Week 24
Secondary outcomes (3)
Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)
The Galderma Chin Retrusion Scale is a 4 point Likert Scale used to assess chin retrusion ranging from "no retrusion" (grade 0) to "severe retrusion" (grade 3)
Measured: Baseline to Week 2, Week 4, Week 12, Week 24
Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)
The Global Aesthetic Improvement Scale is a 5 point Likert Scale in which the blinded investigator can assess change in chin retrusion following aesthetic treatment. The grading scale ranges from "worse" (grade -1) to "very much improved" (grade 3)
Measured: Baseline to Week 2, Week 4, Week 12, Week 24
Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)
This will be done by means of measurement of the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues.
Measured: Baseline to Week 2, Week 4, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start23 Oct 2023
- Primary completion9 Oct 2024
- Study completion9 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin RetrusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336772
- Sponsor's protocol ID
- 10-2023-GAL-SHYP
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial Evaluating Restylane Shaype Versus Juvederm Volux for Chin Augmentation
- ClinicalTrials.gov ID
- NCT06336772
- Acronym / sponsor ID
- 10-2023-GAL-SHYP
- Conditions
- Chin Retrusion
- Keywords
- Chin Augmentation, Hyaluronic Acid Filler, Aesthetic Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 29 Mar 2024 (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.
This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Shaype | Experimental | Device: Restylane ShaypeRestylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group. The participant will be treated at the Baseline visit 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. |
| Juvederm Volux | Active comparator | Device: Juvéderm VoluxJuvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company. The participant will be treated at the Baseline visit 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 (6 listed)
- At the time of consent, male and female subjects 18 years of age and older.
- Patients with established chin retrusion at Baseline (a score of mild, moderate, and severe severity on the Galderma Chin Retrusion Scale).
- 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 (27 listed)
- Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
- 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 Restylane or Juvéderm products, hyaluronic acid filler or amide local anesthetics.
- Patients presenting with porphyria or any other liver diseases.
- Inability to comply with follow-up and abstain from facial injections during the study period.
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 |
|---|---|---|
| Restylane ShaypeHalf (50%) of study participants will receive Restylane Shaype for the treatment of mild to severe chin retrusion | Device | Restylane Shaype |
| Juvéderm VoluxHalf (50%) of study participants will receive Juvéderm Volux for the treatment of mild to severe chin retrusion | Device | Juvederm Volux |
Primary outcome
Statistically significant group differences in the average three-dimensional volumetric increase since baseline
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
As assessed by the Canfield Vectra XT system.
3 secondary outcomes
Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
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 4 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Chin Retrusion
Active, not recruiting
Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
Aging, Chin Retrusion
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 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 Restylane Shaype and Juvéderm Volux in people with Chin Retrusion, 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 6 inclusion and 27 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 4 Feb 2025. 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?
Statistically significant group differences in the average three-dimensional volumetric increase since baseline (time frame: Baseline to Week 2, Week 4, Week 12, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.