Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth). VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China. Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
198
Injection, intradermal
No-treatment control
China-Japan Friendship Hospital /ID# 252139
Beijing, Beijing Municipality, China
Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 231394
Beijing, Beijing Municipality, China
Beijing Hospital /ID# 231393
Beijing, Beijing Municipality, China
Peking University First Hospital /ID# 231392
Xicheng District, Beijing Municipality, China
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 231398
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231396
Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 231937
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 244045
Nanjing, Jiangsu, China
Huashan Hospital, Fudan University /ID# 231395
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 231740
Chengdu, Sichuan, China
...and 1 more locations
The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS)
Responder status based on the Evaluating Investigator's (EI's) live assessment of perioral lines. The POLSS is a 4-point scale from 0 = None, 1 = Mild, 2 = Moderate, to 3 = Severe. An improvement of 1 or more points is an improvement in visibility of perioral lines.
Time frame: Up to Month 2
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the EI
The Evaluating Investigator (EI) will assess global aesthetic improvement of the perioral area by comparing to frontal and oblique view photographs taken at baseline. The GAIS is a 5-point scale from 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, to -2 = Much Worse.
Time frame: Up to Month 2
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the participant
The participant will utilize GAIS to assess global aesthetic improvement of the perioral area by comparing to frontal and oblique view photographs taken at baseline.
Time frame: Up to Month 2
The change from baseline on the FACE-Q Appraisal of Lines: Lips questionnaire
The FACE-Q Appraisal of Lines: Lips is a validated scale used to assess the impact of treatment from the participant's perspective. Participants respond to each item on a scale from 1 = Not at all, 2 = A little, 3 = Moderately, to 4 = Extremely.
Time frame: Up to Month 2
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