Chin RetrusionNCT02833077
A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
A study testing JUVÉDERM VOLUMA® XC in people with Chin Retrusion, run by Allergan at 14 sites in United States.
Trial summary
This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chin Retrusion
- What is being tested?
- JUVÉDERM VOLUMA® XC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 14 sitesUnited States
- Study dates
- 28 Jun 2016to 11 Oct 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chin retrusion
- In good general health
Who cannot join
- Permanent facial implants on the face and/or neck
- Received fat injections below the nose
- Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
- Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
- Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
- Received dermal filler injections in the lips or in the mouth area in the last 12 months
- Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
- Received botulinum toxin treatment below the nose in the last 6 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Dermatology & Laser Center of Charleston Center for Clinical Research
Charleston, South Carolina, 29414
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 01467
DeNova Research
Chicago, Illinois, 60611
Skin Research Institute
Coral Gables, Florida, 33146
Callender Dermatology and Cosmetic Center
Glenn Dale, Maryland, 20769
Williams Plastic Surgery Specialists
Latham, New York, 12110
Baumann Cosmetic and Res. Institute
Miami Beach, Florida, 33137
Image Dermatology, PC
Montclair, New Jersey, 07042
The Center for Dermatology, Cosmetics, & Laser Surgery
Mount Kisco, New York, 10549
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121
Premier Clinical Research; Spokane Dermatology Clinic
Spokane, Washington, 99202
St Louis University Medical Center Dept. of Dermatology
St Louis, Missouri, 63104
Research Institute of the Southeast
West Palm Beach, Florida, 33401
About this study
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.
- Conditions
- Chin Retrusion
- Being tested
- JUVÉDERM VOLUMA® XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM VOLUMA® XCDevice
JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM VOLUMA® XC | Experimental | JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined. Receives: Device: JUVÉDERM VOLUMA® XC |
| No Treatment then JUVÉDERM VOLUMA® XC | Other | No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined. Receives: Device: JUVÉDERM VOLUMA® XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).
Measured: Baseline (up to 30 days prior to randomization) to Month 6
Secondary outcomes (3)
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.
Measured: Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator
The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.
Measured: Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants
The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.
Measured: Baseline (up to 30 days prior to randomization) to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start28 Jun 2016
- Primary completion6 Feb 2018
- Study completion11 Oct 2018
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.
- 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Schumacher, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833077
- Sponsor's protocol ID
- Voluma-006
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2016
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Beer K, Kaufman-Janette J, Bank D, Biesman B, Dayan S, Kim W, Chawla S, Schumacher A. Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L. Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.
PubMed 33347003
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation
- ClinicalTrials.gov ID
- NCT02833077
- Acronym / sponsor ID
- Voluma-006
- Conditions
- Chin Retrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 23 Jul 2020
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 safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in 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 |
|---|---|---|
| JUVÉDERM VOLUMA® XC | Experimental | Device: JUVÉDERM VOLUMA® XCJUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined. |
| No Treatment then JUVÉDERM VOLUMA® XC | Other | Device: JUVÉDERM VOLUMA® XCNo treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chin retrusion
- In good general health
Key exclusion criteria (8 listed)
- Permanent facial implants on the face and/or neck
- Received fat injections below the nose
- Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
- Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
- Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
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 VOLUMA® XCJUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL. | Device | JUVÉDERM VOLUMA® XC, No Treatment then JUVÉDERM VOLUMA® XC |
Primary outcome
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).
3 secondary outcomes
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33347003Beer K, Kaufman-Janette J, Bank D, Biesman B, Dayan S, Kim W, Chawla S, Schumacher A. Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L. Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.
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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.
Andrew Schumacher study director
Allergan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVÉDERM VOLUMA® XC in people with Chin Retrusion, run by Allergan at 14 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 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 23 Jul 2020). 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 With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score (time frame: Baseline (up to 30 days prior to randomization) to 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 NCT02833077, 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 23 Jul 2020.