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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Quality Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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JUVÉDERM® VOLITE™

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

Group Type EXPERIMENTAL

JUVÉDERM® VOLITE™

Intervention Type DEVICE

Injection, intradermal

Control - No Treatment

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

Group Type OTHER

JUVÉDERM® VOLITE™

Intervention Type DEVICE

Injection, intradermal

Control

Intervention Type OTHER

No-treatment control

Interventions

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JUVÉDERM® VOLITE™

Injection, intradermal

Intervention Type DEVICE

Control

No-treatment control

Intervention Type OTHER

Other Intervention Names

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AGN-8015

Eligibility Criteria

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Inclusion Criteria

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

* Participants must have FACE-Q Satisfaction with Skin Scale 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No