Chin RetrusionNCT03597256
Restylane Defyne for Correction of Chin Retrusion
A study testing Restylane Defyne in people with Chin Retrusion, run by Galderma R&D at 1 site in China.
Trial summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chin Retrusion
- 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
- 148 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 9 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participated with signed and dated informed consent form.
- Men or women aged 18 years of age or older of Chinese origin.
- Subjects who were seeking augmentation therapy for chin retrusion.
- GCRS score of 1 or 2 as assessed by the Blinded Evaluator
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
- Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- History of severe or multiple allergies, manifested by anaphylaxis.
- Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
- Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
- Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
- Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
- Conditions
- Chin Retrusion
- Being tested
- Restylane Defyne
- Keywords
- Hyaluronic acid, Chin Retrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane DefyneDevice
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection and optional touch-up injection with Restylane Defyne in chin Receives: Device: Restylane Defyne |
| Control Group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
Measured: At Month 6
Secondary outcomes (2)
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases.
Measured: Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6.
Measured: At Week 4 and Months 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start8 Oct 2018
- Primary completion24 Sep 2019
- Study completion9 Sep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597256
- Sponsor's protocol ID
- 43CH1627
- Status last verified
- May 2024
- First submitted
- 13 Jul 2018
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie Y, Zhao H, Wu W, Xu J, Li B, Wu S, Chen K, Bromee T, Li Q. Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study. Aesthetic Plast Surg. 2024 Mar;48(5):1030-1036. doi: 10.1007/s00266-023-03812-2. Epub 2024 Feb 5.
PubMed 38315229
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion
- ClinicalTrials.gov ID
- NCT03597256
- Acronym / sponsor ID
- 43CH1627
- Conditions
- Chin Retrusion
- Keywords
- Hyaluronic acid, Chin Retrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Restylane DefyneSingle injection and optional touch-up injection with Restylane Defyne in chin |
| Control Group | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participated with signed and dated informed consent form.
- Men or women aged 18 years of age or older of Chinese origin.
- Subjects who were seeking augmentation therapy for chin retrusion.
- GCRS score of 1 or 2 as assessed by the Blinded Evaluator
Key exclusion criteria (7 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
- Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- History of severe or multiple allergies, manifested by anaphylaxis.
- Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
- Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
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 DefyneIntradermal injection | Device | Treatment Group |
Primary outcome
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
Time frame: At Month 6
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
2 secondary outcomes
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Time frame: Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
Time frame: At Week 4 and Months 3, and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38315229Xie Y, Zhao H, Wu W, Xu J, Li B, Wu S, Chen K, Bromee T, Li Q. Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study. Aesthetic Plast Surg. 2024 Mar;48(5):1030-1036. doi: 10.1007/s00266-023-03812-2. Epub 2024 Feb 5.
- Individual participant dataSharing planned: No
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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.
Q-Med AB study director
Galderma R&D
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 Defyne in people with Chin Retrusion, run by Galderma R&D at 1 site in China.
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 4 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 12 Jun 2024. 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 China. 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 12 Jun 2024). 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?
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) (time frame: At Month 6). 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 NCT03597256, which also lists 1 linked publication.
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 12 Jun 2024.