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This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLUX XC | Experimental | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
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| No-treatment control | Experimental | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOLUX XC | Device | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) | The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Sartor | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| Westside Aesthetics |
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Study consists of 2 groups: Treatment and Control. The treatment group rec'd treatment Day 1 and was followed up to Month 12. At Month 12 they had the option to exit the study or receive maintenance treatment with an add'l 3 months of follow-up after treatment. The control group followed a 6-month no-treatment control period after which they had the option to exit the study or proceed to the post-control period where they receive treatment with 12 months of follow-up after their last treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-treatment Control | No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Control Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2019 | Aug 15, 2022 |
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| No-treatment control | Other | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period. |
|
| Month 6 |
| Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS) | The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported. | Month 6 |
| Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score | The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best) | Baseline to Month 6 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Artemedica | Santa Rosa | California | 95401 | United States |
| Center for Dermatology and Dermatologic Surgery | Washington D.C. | District of Columbia | 20037 | United States |
| Susan H Weinkle, MD | Bradenton | Florida | 34209 | United States |
| Hevia Cosmetic Dermatology | Coral Gables | Florida | 33134 | United States |
| Skin Research Institute LLC | Coral Gables | Florida | 33146 | United States |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | United States |
| DeNova Research dba Arano, LLC | Chicago | Illinois | 60611 | United States |
| Callender Center for Clinical Research | Glenn Dale | Maryland | 20769 | United States |
| MDLSV | Hunt Valley | Maryland | 21030 | United States |
| Williams Center | Latham | New York | 12110 | United States |
| The Center for Dermatology, Cosmetic & Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Center aesthetic and dermatology | New York | New York | 10003 | United States |
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
| Aesthetic Solutions, PA. | Chapel Hill | North Carolina | 27517 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Houston | Texas | 77056 | United States |
| SkinDC | Arlington | Virginia | 22209 | United States |
| FG001 |
| VOLUX XC |
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. VOLUX XC: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
| Participants Treated as Randomized |
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| Participants Not Treated as Randomized | Participant was randomized to the treatment group (VOLUX XC) but subsequently found to not meet inclusion criteria and was discontinued at randomization without receiving treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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| Opt VOLUX Treatment Follow Up Period |
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| VOLUX Maintenance Treatment Period |
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Modified intent-to-treat (mITT) Population included all randomized participants with non-missing baseline on the ALJDS scale on both sides of the jaw
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| ID | Title | Description |
|---|---|---|
| BG000 | No-treatment Control | No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. |
| BG001 | VOLUX XC | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. VOLUX XC: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 | Number | participants |
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| Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) | If the baseline ALJDS score is different for left and right jaws, then the participant is included under the worse score. | Number | units on a scale |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) | The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme) | All modified intent-to-treat (mITT) participants who have Month 6 assessment on the ALJDS scale on both sides of the jaw. Multiple imputation was performed on participants with missing data for the Month 6 assessment on the ALJDS on both sides of jaw | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. | Modified intent-to-treat (mITT) Population included all randomized participants with non-missing baseline on the ALJDS scale on both sides of the jaw | Posted | Count of Participants | Participants | Month 6 |
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| Secondary | Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS) | The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported. | As per the Protocol and the Statistical Analysis Plan: During the Control Period these data were collected only for participants that were randomized and received VOLUX treatment at the beginning of the Control Period | Posted | Count of Participants | Participants | Month 6 |
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| Secondary | Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score | The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best) | As per the Protocol and the Statistical Analysis Plan: During the Control Period these data were collected only for participants that were randomized and received VOLUX treatment at the beginning of the Control Period | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 6 |
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12 to 17 months for the treatment group and 6 to 20 months for the control group.
All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.
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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 | No-treatment Control | No-treatment during the control period. No-treatment control: No-treatment during the control period. (randomization to Month 6) | 0 | 50 | 1 | 50 | 0 | 50 |
| EG001 | VOLUX XC Treatment | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. VOLUX XC: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. | 0 | 156 | 17 | 156 | 9 | 156 |
| EG002 | Optional VOLUX XC Treatment Post Control | Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period (optional treatment to study exit). | 0 | 42 | 3 | 42 | 5 | 42 |
| EG003 | VOLUX Maintenance Treatment | Participants in the VOLUX XC Treatment population who received VOLUX maintenance treatment at Month 12 | 0 | 87 | 4 | 87 | 1 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE HYPERSENSITIVITY | General disorders | MedDRA 22.1 | Systematic Assessment |
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| INJECTION SITE NODULE | General disorders | MedDRA 22.1 | Systematic Assessment |
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| BACTERIAL VAGINOSIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| IMPLANT SITE INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| INJECTION SITE INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| SCHWANNOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| TRIPLE NEGATIVE BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| BREAST NECROSIS | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2020 | Aug 15, 2022 | SAP_001.pdf |
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| 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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| Severe |
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| Extreme |
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