Jawline Definition Clinical Trial
Official title:
A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Verified date | September 2022 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
Status | Completed |
Enrollment | 206 |
Est. completion date | January 26, 2021 |
Est. primary completion date | February 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3 - Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition - Written Informed Consent (IC) has been obtained Exclusion Criteria: - Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study - Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study - Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study - Has received deoxycholic acid treatment in the submental region in the last 6 months - Has active autoimmune disease - Females who are pregnant, nursing, or planning a pregnancy during the course of the study |
Country | Name | City | State |
---|---|---|---|
United States | SkinDC | Arlington | Virginia |
United States | Bellaire Dermatology Associates | Bellaire | Texas |
United States | Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama |
United States | Susan H Weinkle, MD | Bradenton | Florida |
United States | Aesthetic Solutions, PA. | Chapel Hill | North Carolina |
United States | DeNova Research dba Arano, LLC | Chicago | Illinois |
United States | Hevia Cosmetic Dermatology | Coral Gables | Florida |
United States | Skin Research Institute LLC | Coral Gables | Florida |
United States | Callender Center for Clinical Research | Glenn Dale | Maryland |
United States | Suzanne Bruce and Associates, P.A., The Center for Skin Research | Houston | Texas |
United States | MDLSV | Hunt Valley | Maryland |
United States | Williams Center | Latham | New York |
United States | Westside Aesthetics | Los Angeles | California |
United States | Baumann Cosmetic and Research Institute | Miami | Florida |
United States | The Center for Dermatology, Cosmetic & Laser Surgery | Mount Kisco | New York |
United States | Center aesthetic and dermatology | New York | New York |
United States | Laser & Skin Surgery Center of New York | New York | New York |
United States | Artemedica | Santa Rosa | California |
United States | Center for Dermatology and Dermatologic Surgery | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | Month 6 | |
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. | Month 6 | |
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. | Month 6 | |
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) | Baseline to Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05622812 -
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
|
N/A |