Chin Retrusion
Conditions
Brief summary
This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.
Interventions
DEVICEJUVÉDERM VOLUMA® XC
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chin retrusion * In good general health
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire | Baseline (up to 30 days prior to randomization) to Month 6 | 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. |
| 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 | Baseline (up to 30 days prior to randomization) to Month 6 | 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. |
| Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants | Baseline (up to 30 days prior to randomization) to Month 6 | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 221 participants were enrolled in the study, with enrollment defined as signing the informed consent form. A total of 29 enrolled participants were screen failures (did not meet eligibility criteria). Thus, a total of 192 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| JUVÉDERM VOLUMA® XC 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 mL for both treatments combined. | 144 |
| No Treatment Then JUVÉDERM VOLUMA® XC 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. | 48 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 10 | 1 |
| Overall Study | Personal Reasons | 6 | 4 |
| Overall Study | Protocol Deviation | 0 | 1 |
Baseline characteristics
| Characteristic | JUVÉDERM VOLUMA® XC | Total | No Treatment Then JUVÉDERM VOLUMA® XC |
|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 13.4 | 49.8 years STANDARD_DEVIATION 13.6 | 48.9 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 33 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 159 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 29 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 116 Participants | 157 Participants | 41 Participants |
| Region of Enrollment North America | 144 Participants | 192 Participants | 48 Participants |
| Sex: Female, Male Female | 129 Participants | 170 Participants | 41 Participants |
| Sex: Female, Male Male | 15 Participants | 22 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 48 | 0 / 38 |
| other Total, other adverse events | 0 / 144 | 0 / 48 | 0 / 38 |
| serious Total, serious adverse events | 10 / 144 | 4 / 48 | 1 / 38 |
Outcome results
Primary
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).
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Population: The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number of participants analyzed were the participants with analysis values at both Baseline and Post-baseline during the specified time period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVÉDERM VOLUMA® XC | Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score | 56.3 percentage of participants |
| No Treatment Then JUVÉDERM VOLUMA® XC | Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score | 27.5 percentage of participants |
Comparison: Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.p-value: 0.001995% CI: [11.16, 45.6]Fisher's exact test
Secondary
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.
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Population: The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number of participants analyzed were the participants with analysis values at both Baseline and Post-baseline during the specified time period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLUMA® XC | Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire | Baseline | 35.7 score on a scale | Standard Deviation 17.7 |
| JUVÉDERM VOLUMA® XC | Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire | Change from Baseline to Month 6 | 35.6 score on a scale | Standard Deviation 23.2 |
| No Treatment Then JUVÉDERM VOLUMA® XC | Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire | Baseline | 35.3 score on a scale | Standard Deviation 14.9 |
| No Treatment Then JUVÉDERM VOLUMA® XC | Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire | Change from Baseline to Month 6 | -3.3 score on a scale | Standard Deviation 11.5 |
p-value: <0.0001Two sided paired t-test
Secondary
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.
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Population: Participants in the mITT population who were randomized to the treatment group and received at least 1 study treatment with available data were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVÉDERM VOLUMA® XC | Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants | 87.3 percentage of participants |
Secondary
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.
Time frame: Baseline (up to 30 days prior to randomization) to Month 6
Population: The mITT population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group. Overall number analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVÉDERM VOLUMA® XC | 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 | 91.2 percentage of participants |
| No Treatment Then JUVÉDERM VOLUMA® XC | 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 | 19.5 percentage of participants |