Chin RetrusionPhase 3NCT04559984
JUVÉDERM VOLUX® for Chin Retrusion in China
A Phase 3 study testing JUVÉDERM VOLUX® in people with Chin Retrusion, run by Allergan at 7 sites in China.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesChina
- Study dates
- 15 Oct 2020to 26 Aug 2022
- Phase
- Phase 3
- 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 must be at least 18 years of age at the time of signing the ICF
- Male and female
- Participants of Chinese descent
- Participants seeking improvement of chin retrusion
- Chin retrusion (G-Sn-Pog angle of < 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software
- Has moderate to severe chin retrusion on the CACRS as determined by EI 2D image evaluation
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- Has a reasonable goal for aesthetic improvement in chin retrusion and is able to achieve a 1-point improvement in CACRS score with study intervention in the judgment of TI
- Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Written informed consent from the participant has been obtained prior to any study-related procedures
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
Who cannot join
- History of tendency to develop hypertrophic scarring
- History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein
- Active autoimmune disease
- Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention)
- Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms
- Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
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- Permanent dermal filler injected below the subnasale
- Semi-permanent dermal filler or fat injected below the subnasale within 36 months before enrollment
- Temporary dermal filler injected below the subnasale within 12 months before enrollment
- Orthodontics procedures within 12 months before enrollment
- Botulinum toxin treatment in the chin area within 6 months before enrollment
- Mesotherapy or cosmetic facial procedures (eg, face-lift, brow lift, facial reconstructive surgery, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) below the subnasale within 6 months before enrollment
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment
- Abnormal and clinically significant results according to the TI or designee, on hematology, clinical chemistry, or urinalysis
- Females who are pregnant, nursing, or planning a pregnancy during the study
- Tattoos, piercings or scars that would interfere with study visual assessments and 3D measurements of chin area in the judgment of TI
- Trauma to the chin or has residual deficiencies, congenital deformities, or scarring which would impact the trial data evaluation in the judgment of TI
- Menstruation at the time of study intervention (study intervention may be delayed as necessary to accommodate menstrual period cessation)
- The participant has a condition or is in a situation which, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441
Beijing, Beijing Municipality, 100144
Beijing Hospital /ID# 224440
Beijing, Beijing Municipality, 100730
Peking University International Hospital /ID# 224438
Beijing, 102206
Nanfang Hospital of Southern Medical University /ID# 224442
Guangzhou, Guangdong, 510515
Nanjing Drum Tower Hospital /ID# 224439
Nanjing, Jiangsu, 210008
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445
Shanghai, 200011
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444
Wuhan, Hubei, 430022
About this study
Official title: A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLUX® Injectable Gel for the Enhancement of the Chin to Correct Moderate to Severe Retrusion in Chinese Adults
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.
- 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 |
|---|---|---|
| JUVÉDERM VOLUX® | Experimental | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator. Receives: Device: JUVÉDERM VOLUX® |
| Control- No treatment | Other | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. 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 glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.
Measured: Change from Baseline to Week 24
Secondary outcomes (4)
China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
The CACRS is a validated 5-point ordinal scale developed by Allergan to grade the severity of chin retrusion. The scale ranges from 0=none to 4=severe.
Measured: Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q.
Measured: Week 24
Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24
The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Week 24
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one or more TEAEs
Measured: Up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Oct 2020
- Primary completion26 Aug 2022
- Study completion26 Aug 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 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
- NCT04559984
- Sponsor's protocol ID
- 1868-701-008
- Status last verified
- Aug 2023
- First submitted
- 17 Sep 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLUX® Injectable Gel for the Enhancement of the Chin to Correct Moderate to Severe Retrusion in Chinese Adults
- ClinicalTrials.gov ID
- NCT04559984
- Acronym / sponsor ID
- 1868-701-008
- Conditions
- Chin Retrusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 23 Sep 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.
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM VOLUX® | Experimental | Device: JUVÉDERM VOLUX®Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator. |
| Control- No treatment | Other | Device: JUVÉDERM VOLUX®No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must be at least 18 years of age at the time of signing the ICF
- Male and female
- Participants of Chinese descent
- Participants seeking improvement of chin retrusion
- Chin retrusion (G-Sn-Pog angle of < 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software
Key exclusion criteria (19 listed)
- History of tendency to develop hypertrophic scarring
- History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein
- Active autoimmune disease
- Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention)
- Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms
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 | Control- No treatment, JUVÉDERM VOLUX® |
Primary outcome
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
Time frame: Change from Baseline to Week 24
The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.
4 secondary outcomes
China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
Time frame: Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
Time frame: Week 24
Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24
Time frame: Week 24
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
Time frame: Up to week 52
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 Aug 2023.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
ALLERGAN INC. study director
Allergan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JUVÉDERM VOLUX® in people with Chin Retrusion, run by Allergan at 7 sites 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 10 inclusion and 19 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24 (time frame: Change from Baseline to 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 21 Aug 2023.