Chin RetrusionNCT04687046
A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence
An observational study of Chin Retrusion, run by Allergan at 1 site in China.
Trial summary
This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data. 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?
- JUVÉDERM VOLUX®
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 28 Feb 2022
- Phase
- Observational
- 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
Study population: All participants receive VOLUX treatment at Hainan Boao Super Hospital, with screening and follow-up visits at Hainan Boao Super Hospital or another hospital.
Who may be able to join
- -Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.
Who cannot join
- History of hypersensitivity to lidocaine,HA, or Streptococcal protein
- History of tendency to develop hypertrophic scarring
- Untreated epilepsy or porphyria
- Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
- Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
- Permanent filler, semi-permanent filler, or fat injected in the treatment area
- Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment
- Females who self-report current pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Evidence Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults
This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.
Read the detailed description
There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.
- Conditions
- Chin Retrusion
- Being tested
- JUVÉDERM VOLUX®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM VOLUX®Device
JUVÉDERM VOLUX® injectable gel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 JUVÉDERM VOLUX® with 3D Imaging | Treatment will be determined according to the physician's experience and Directions for Use. Cohort 1 will have follow-up on-site visits, including 3D imaging, at Months 1, 3, 6, and 12. Receives: Device: JUVÉDERM VOLUX® | |
| Cohort 2 JUVÉDERM VOLUX® | Treatment will be determined according to the physician's experience and Directions for Use. Cohort 2 will have follow-up on-site visits at Months 1 and 3 and follow-up telephone calls at Months 6 and 12. Receives: Device: JUVÉDERM VOLUX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Measured: Baseline, Month 3
Secondary outcomes (4)
Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5- point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
Participant will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Month 3
The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits
The number of patients who experienced ISRs
Measured: Month 1, 3, 6, and 12
The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits
The number of patients who experienced AEs
Measured: Month 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start4 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687046
- Sponsor's protocol ID
- 1868-705-008
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Evidence Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults
- ClinicalTrials.gov ID
- NCT04687046
- Acronym / sponsor ID
- 1868-705-008
- Conditions
- Chin Retrusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Dec 2020 (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 will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.
Detailed description
There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 JUVÉDERM VOLUX® with 3D Imaging | – | Device: JUVÉDERM VOLUX®Treatment will be determined according to the physician's experience and Directions for Use. Cohort 1 will have follow-up on-site visits, including 3D imaging, at Months 1, 3, 6, and 12. |
| Cohort 2 JUVÉDERM VOLUX® | – | Device: JUVÉDERM VOLUX®Treatment will be determined according to the physician's experience and Directions for Use. Cohort 2 will have follow-up on-site visits at Months 1 and 3 and follow-up telephone calls at Months 6 and 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants receive VOLUX treatment at Hainan Boao Super Hospital, with screening and follow-up visits at Hainan Boao Super Hospital or another hospital.
Key inclusion criteria (1 listed)
- -Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.
Key exclusion criteria (8 listed)
- History of hypersensitivity to lidocaine,HA, or Streptococcal protein
- History of tendency to develop hypertrophic scarring
- Untreated epilepsy or porphyria
- Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
- Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
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 |
|---|---|---|
| JUVÉDERM VOLUX®JUVÉDERM VOLUX® injectable gel | Device | Cohort 1 JUVÉDERM VOLUX® with 3D Imaging, Cohort 2 JUVÉDERM VOLUX® |
Primary outcome
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Time frame: Baseline, Month 3
4 secondary outcomes
Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
Time frame: Month 3
The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits
Time frame: Month 1, 3, 6, and 12
The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits
Time frame: Month 1, 3, 6, and 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 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
ALLERGAN INC. study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chin Retrusion, run by Allergan 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 1 inclusion and 8 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 21 Feb 2023. 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?
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?
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle (time frame: Baseline, Month 3). 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 21 Feb 2023.