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This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUMA® XC | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (up to 30 days prior to randomization) to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Schumacher | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. | San Diego | California | 92121 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33347003 | Derived | 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. |
| Label | URL |
|---|---|
| More Information | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 milliliters (mL) for both treatments combined. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2017 | Jul 10, 2020 |
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| 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. | 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. | Baseline (up to 30 days prior to randomization) to Month 6 |
| Skin Research Institute |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Baumann Cosmetic and Res. Institute | Miami Beach | Florida | 33137 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| DeNova Research | Chicago | Illinois | 60611 | United States |
| Callender Dermatology and Cosmetic Center | Glenn Dale | Maryland | 20769 | United States |
| SkinCare Physicians of Chestnut Hill | Chestnut Hill | Massachusetts | 01467 | United States |
| St Louis University Medical Center Dept. of Dermatology | St Louis | Missouri | 63104 | United States |
| Image Dermatology, PC | Montclair | New Jersey | 07042 | United States |
| Williams Plastic Surgery Specialists | Latham | New York | 12110 | United States |
| The Center for Dermatology, Cosmetics, & Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Dermatology & Laser Center of Charleston Center for Clinical Research | Charleston | South Carolina | 29414 | United States |
| Nashville Centre for Laser and Facial Surgery | Nashville | Tennessee | 37203 | United States |
| Premier Clinical Research; Spokane Dermatology Clinic | Spokane | Washington | 99202 | United States |
| 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. |
| Participants Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-Treat (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Number | percentage of participants | Baseline (up to 30 days prior to randomization) to Month 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (up to 30 days prior to randomization) to Month 6 |
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| 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. | 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. | Posted | Number | percentage of participants | Baseline (up to 30 days prior to randomization) to Month 6 |
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| 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. | 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. | Posted | Number | percentage of participants | Baseline (up to 30 days prior to randomization) to Month 6 |
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JUVÉDERM VOLUMA® XC: Up to 12 months following treatment. No Treatment then JUVÉDERM VOLUMA® XC: Up to 6 months during No Treatment; Up to 6 months following treatment (Up to Month 12)
Safety population included all participants randomized to the treatment group who received at least 1 study device treatment or all participants randomized to the control group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 144 | 10 | 144 | 0 | 144 |
| EG001 | No Treatment | Participants who received no treatment for the first 6 months. | 0 | 48 | 4 | 48 | 0 | 48 |
| EG002 | JUVÉDERM VOLUMA® XC After No Treatment | Participants who received optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6 after no treatment for 6 months. 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. | 0 | 38 | 1 | 38 | 0 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | 21.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | 21.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | 21.0 | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | 21.0 | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Injection site cellulitis | Infections and infestations | 21.0 | Systematic Assessment |
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| Injection site inflammation | General disorders | 21.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | 21.0 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | 21.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | 21.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | 21.0 | Systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Invasive papillary breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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| Breast cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 1, 2017 | Jul 10, 2020 | Prot_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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