A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China For the Improvement of Skin Quality
NCT Number: NCT06547125
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Skin Quality Deficit
Interventions: DEVICE: JUVÉDERM® VOLITE™|OTHER: Control
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2026-06-25
Locations: Peking University First Hospital /ID# 260957, Xicheng District, Beijing, 100034, China|Nanjing Drum Tower Hospital /ID# 260950, Nanjing, Jiangsu, 210008, China|Zhongda Hospital Southeast University /ID# 260951, Nanjing, Jiangsu, 210009, China|Hangzhou First People's Hospital /ID# 260952, Hangzhou, Zhejiang, 310003, China

Summary:
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 the treatment of fine lines and improving skin quality.

VOLITE is an investigational device being developed for improving skin quality. 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 skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 102 participants will be enrolled in the study at approximately 8 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 regular 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.

Primary Outcome Measures: Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS), A "responder" is a participant who shows improvement in the overall aesthetic assessment on the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'., Month 2|Number of Participants with Adverse Events (AEs), An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other persons, whether or not related to the investigational medical device, and whether anticipated or unanticipated., Up to approximately Month 12
Secondary Outcome Measures: Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS, A "responder" is a participant who shows improvement in the overall aesthetic assessment in the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'., Month 2|Percentage of Participants Achieving "Responder" Status for Treating Investigator's (TI) Assessment of Global Aesthetic Improvement of Skin Quality on the Treatment Area using GAIS, A "responder" is a participant who shows improvement in the overall aesthetic assessment in the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'., Month 2|Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Questionnaire, The FACE Q Satisfaction with Skin is a validated 12-item questionnaire that asks subjects to report their level of satisfaction with how their facial skin looked "in the past week." Response options are on a 4-point Likert scale ranging from Very dissatisfied to Very Satisfied. Total score is Rasch transformed from 0 (worst) to 100 (best)., Month 2|Change from Baseline in Treatment Area Skin Hydration Measurement, The trained designee will measure skin hydration using the assigned instrument at the designated study visits., Month 2|Percentage of Participants with Responder Status based on EI's Live Assessments of Hydration Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Hydration, A "responder" is a participant who shows aesthetic improvement in hydration of the treatment area ("Improved," "Much Improved," or "Very Much Improved" on the scale)., Month 2|Percentage of Participants with Responder Status based on EI's Live Assessments of Radiance Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Radiance, A "responder" is a participant who shows aesthetic improvement in radiance of the treatment area ("Improved," "Much Improved," or "Very Much Improved" on the scale)., Month 2