Chin AugmentationARTISTNCT06428214
A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies
A study testing Restylane Shaype, Restylane Defyne and Restylane Lyft lidocaine in people with Chin Augmentation, run by Galderma R&D at 3 sites in Canada.
Trial summary
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chin Augmentation
- What is being tested?
- Restylane Shaype, Restylane Defyne and Restylane Lyft lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesCanada
- Study dates
- 13 May 2024to 24 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
- Males or non-pregnant, non-breastfeeding females, over the age of 18.
- Intent to receive treatment for temporary augmentation in the chin region.
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
- Any previous aesthetic procedures or implants.
- Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
- Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
- Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Galderma Investigational Site 8379
Burlington, Ontario, L7N3N2
Galderma Investigational Site # 8754
Vancouver, British Columbia, V6H 4E1
Galderma Investigational Site 8690
Westmount, Quebec, H3Z 1C3
About this study
Official title: A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
- Conditions
- Chin Augmentation
- Being tested
- Restylane Shaype, Restylane Defyne, Restylane Lyft lidocaine
- Keywords
- lower face, Mid face
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane ShaypeDevice
Injection
Restylane DefyneDevice
Injection
Restylane Lyft lidocaineDevice
Injection
| Study group | Role | What they receive |
|---|---|---|
| Restylane Shaype | Experimental | Participants will receive Restylane Shaype in the chin area only. Receives: Device: Restylane Shaype |
| Restylane Shaype with Restylane Defyne | Other | Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Receives: Device: Restylane Shaype; Device: Restylane Defyne |
| Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine | Other | Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline. Receives: Device: Restylane Shaype; Device: Restylane Defyne; Device: Restylane Lyft lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
Measured: At week 8
Secondary outcomes (6)
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4
Measured: At week 4
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8
Measured: At weeks 4 and 8
Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8
Measured: At week 8
Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8
Measured: At week 8
Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
Measured: At week 8
Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start13 May 2024
- Primary completion25 Jul 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin AugmentationStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428214
- Sponsor's protocol ID
- 05DF2307
- Acronym
- ARTIST
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface
- ClinicalTrials.gov ID
- NCT06428214
- Acronym / sponsor ID
- ARTIST / 05DF2307
- Conditions
- Chin Augmentation
- Keywords
- lower face, Mid face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 24 May 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.
The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restylane Shaype | Experimental | Device: Restylane ShaypeParticipants will receive Restylane Shaype in the chin area only. |
| Restylane Shaype with Restylane Defyne | Other | Device: Restylane Shaype, Device: Restylane DefyneParticipants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. |
| Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine | Other | Device: Restylane Shaype, Device: Restylane Defyne, Device: Restylane Lyft lidocaineParticipants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
- Males or non-pregnant, non-breastfeeding females, over the age of 18.
- Intent to receive treatment for temporary augmentation in the chin region.
Key exclusion criteria (7 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
- Any previous aesthetic procedures or implants.
- Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
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 ShaypeInjection | Device | Restylane Shaype, Restylane Shaype with Restylane Defyne, Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine |
| Restylane DefyneInjection | Device | Restylane Shaype with Restylane Defyne, Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine |
| Restylane Lyft lidocaineInjection | Device | Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine |
Primary outcome
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8
Time frame: At week 8
6 secondary outcomes
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4
Time frame: At week 4
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8
Time frame: At weeks 4 and 8
Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8
Time frame: At week 8
Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8
Time frame: At week 8
Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8
Time frame: At week 8
Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8
Time frame: At week 8
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 31 Jan 2025.
Related trials for Chin Augmentation
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Shaype, Restylane Defyne and Restylane Lyft lidocaine in people with Chin Augmentation, run by Galderma R&D at 3 sites 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 3 inclusion and 7 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8 (time frame: At week 8). 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 31 Jan 2025.