A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality

AbbVie

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Skin Quality Deficit

Treatments: Other: Control; Device: JUVÉDERM® VOLITE™

Study type: Interventional

Funder types: Industry

Identifiers

NCT06547125

M24-486

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

JUVÉDERM® VOLITE™

Experimental group

Description:

Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment.

Treatment:

Device: JUVÉDERM® VOLITE™

Control - No Treatment

Other group

Description:

Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment.

Treatment:

Device: JUVÉDERM® VOLITE™

Other: Control