Chin RetrusionNCT03624816
A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion
A study testing Restylane Defyne in people with Chin Retrusion and Chin Augmentation, run by Galderma R&D at 11 sites in United States.
Trial summary
To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chin Retrusion, Chin Augmentation
- What is being tested?
- Restylane Defyne
- 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
- 11 sitesUnited States
- Study dates
- 21 Aug 2018to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion
Who cannot join
- Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
- Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
WIDLS Chevy Chase
Chevy Chase, Maryland, 20815
Skin Research Institute, LLC
Coral Gables, Florida, 33146
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, 21030
Westside Aesthetics
Los Angeles, California, 90025
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Etre Cometic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Union Square Laser Dermatology
New York, New York, 10003
Marcus Facial Plastic Surgery
Redondo Beach, California, 90277
Moradi M.D.
Vista, California, 92083
Wilmington Dermatology and Laser Center
Wilmington, North Carolina, 28405
About this study
Official title: A Randomized, No-treatment Controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Defyne in the Chin for Augmentation and Correction of Chin Retrusion
To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.
Read the detailed description
This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion.
This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate).
Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject.
At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled
- Conditions
- Chin Retrusion, Chin Augmentation
- Being tested
- Restylane Defyne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane DefyneDevice
hyaluronic acid dermal filler gel
| Study group | Role | What they receive |
|---|---|---|
| Restylane Defyne | Experimental | injection with Restylane Defyne Receives: Device: Restylane Defyne |
| Control | No intervention | no-treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator
Measured: 12 weeks after baseline
Secondary outcomes (5)
Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)
Summary of change from Baseline to Week 12 in the FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). If missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Measured: 12 weeks after last injection
Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion
Response rates, defined by at least 1 point improvement from baseline using the Galderma Chin Retrusion Scale (GCRS), as assessed by the Blinded Evaluator, at 24,36, and 48 weeks after the last injection for the treatment group or after baseline if randomized to no treatment
Measured: 24, 36, and 48 weeks after last injection
Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale
Aesthetic improvement (overall appearance) after treatment with Restylane® Defyne compared to no-treatment control, as determined by assessments using the Global Aesthetic Improvement Scale (GAIS). Assessments were performed at 12, 24, 36, and 48 weeks after treatment. Treating Investigators and subjects separately rated aesthetic improvement of the chin from baseline appearance, where a higher score reflects reporting of greater improvement. The subjects and Investigators select a score from the following categorical scale: Very much improved = 3; Much improved = 2; Improved = 1; No change = 0; Worse = -1; Much worse = -2; Very much worse = -3. Scores range from -3 (worst) to 3 (best). Higher scores reflect a better outcome. The Responder Rate is defined as the number and percent of subjects with a rating of at least "Improved" based off of subject's/investigator's (as appropriate) assessment of the GAIS.
Measured: 12, 24, 36, and 48 weeks after last injection
Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)
Summary of Change from Baseline to Week 24 in FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). IIf missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Measured: 24, 36, and 48 weeks after last injection
Evaluate Volume Change in the Treated Area Using 3D Imaging
Summary of Total Volume Change in the Chin Area Measured by Digital 3D Photography at Each Visit (ITT Population). Total volume change corresponds to net volume change from baseline in the chin area.
Measured: 12, 24, 36, and 48 weeks after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start21 Aug 2018
- Primary completion7 Mar 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chin RetrusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 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
- NCT03624816
- Sponsor's protocol ID
- 43USCH1702
- Status last verified
- Sep 2022
- First submitted
- 7 Aug 2018
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, No-treatment Controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Defyne in the Chin for Augmentation and Correction of Chin Retrusion
- ClinicalTrials.gov ID
- NCT03624816
- Acronym / sponsor ID
- 43USCH1702
- Conditions
- Chin Retrusion, Chin Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.
Detailed description
This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion.
This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate).
Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject.
At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Defyne | Experimental | Device: Restylane Defyneinjection with Restylane Defyne |
| Control | No intervention | –no-treatment control |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion
Key exclusion criteria (2 listed)
- Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
- Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents
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 Defynehyaluronic acid dermal filler gel | Device | Restylane Defyne |
Primary outcome
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
Time frame: 12 weeks after baseline
subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator
5 secondary outcomes
Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)
Time frame: 12 weeks after last injection
Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion
Time frame: 24, 36, and 48 weeks after last injection
Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale
Time frame: 12, 24, 36, and 48 weeks after last injection
Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)
Time frame: 24, 36, and 48 weeks after last injection
Evaluate Volume Change in the Treated Area Using 3D Imaging
Time frame: 12, 24, 36, and 48 weeks after last injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Defyne in people with Chin Retrusion and Chin Augmentation, run by Galderma R&D at 11 sites in United States.
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 2 inclusion and 2 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale (time frame: 12 weeks after baseline). 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 6 Oct 2022.