Clinical trial NCT06547125: A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality
Official title: Multicenter, Evaluator-Blinded, Randomized, No-Treatment Controlled Study of the Effectiveness and Safety of JUVÉDERM® VOLITE™ Injectable Gel for the Improvement in Skin Quality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Skin Quality Deficit
Keywords: Skin Quality Deficit
Juvederm Volite
AGN-8015
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 135 participants will be enrolled in the study at approximately 6 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.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin types II-IV
* Participants' FACE-Q Satisfaction with Skin Questionnaire scores must meet the following criteria:

  * Participants must have FACE-Q Satisfaction with Skin Questionnaire sum of raw scores of 39 or less
  * Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions:

    * How hydrated your facial skin looks?
    * How radiant your facial skin looks?

Exclusion Criteria:

* Any skin condition in the face area that might not be suitable for injection
* Uncontrolled systemic disease
* History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
* Active autoimmune disease
* Tendency to develop hypertrophic scarring
* Currently undergoing chemotherapy/radiotherapy
* Is undergoing orthodontia before enrollment or is planning to undergo it during the study

Primary outcomes:
measure: 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)
timeFrame: Month 2
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately Month 12
Secondary outcomes:
measure: Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS
timeFrame: Month 2
measure: 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
timeFrame: Month 2
measure: Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Questionnaire
timeFrame: Month 2
measure: 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
timeFrame: Month 2
measure: 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
timeFrame: Month 2
measure: Change from Baseline in Treatment Area Skin Elasticity Measurement
timeFrame: Month 2
measure: Change from Baseline in Treatment Area Skin Hydration Measurement
timeFrame: Month 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital /ID# 260959
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 260957
state: Beijing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 260950
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 260951
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 261582
state: Shanghai
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital /ID# 260952
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: