Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face

NCT05355454 | Completed

• 1 other identifier: VIV-STYL-XXL-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Conditions

Volume Deficiency in the Mid-Face; Aging; Aesthetics

Keywords

Mid-Face; Hyaluronic Acid; Volume; Aging; Aesthetics

Outcome Measures

Primary Outcomes (1)

• Mid-Face Volumetric change

  Mean volumetric change between the treatment group and no-treatment control group at 24 (V4) weeks after baseline (V1)

  24 weeks after baseline

Secondary Outcomes (11)

• Mid-Face Volumetric change

  4, and 12 weeks after baseline

• Mid-Face Volumetric change

  4, 12, 24, 48, and 72 weeks after initial treatment

• Global Aesthetic Improvement, by the Subjects

  4, 12, and 24 weeks after baseline

• Global Aesthetic Improvement, by the Subjects

  4, 12, 24, 48, and 72 weeks after initial treatment

• Global Aesthetic Improvement, by the Investigators

  4, 12, and 24 weeks after baseline

Study Arms (2)

STYLAGE® XXL Treatment Group

EXPERIMENTAL

Subjects randomized (5:1 ratio) to receive an initial treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL.

Device: STYLAGE® XXL

No-Treatment Control Group, then Delayed Treatment with STYLAGE® XXL

OTHER

No-Treatment for the first 6-month, then subjects will receive a delayed treatment with STYLAGE® XXL Crosslinked Hyaluronic Acid Gel up to 8mL, based on the PI's assessment, in combination with the aesthetic goal of the subject, then an optional touch-up treatment session 4 weeks later, up to 4mL. Subjects will also be offered an optional retreatment at week 72 after initial treatment, up to 8mL.

Device: STYLAGE® XXL

Interventions

STYLAGE® XXL DEVICE

Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek at the first session, on each side of the face. Up to 1.0 mL in the zygomaticomalar region and optionally up to 1.0 mL in the anteromedial cheek for the optional touch-up session, on each side of the face. Up to 2.0 mL will be injected in the zygomaticomalar region and optionally up to 2.0 mL in the anteromedial cheek before study exit, on each side of the face.

STYLAGE® XXL Treatment Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 30 and 65 years
• Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
• Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
• Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
• Psychologically able to understand the study related information and to give a written informed consent
• Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed
• Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study
• Affiliated to a health social security system (for France only)

You may not qualify if:

• In terms of population:
• Pregnant or breastfeeding woman, or planning a pregnancy during the study
• Scars, moles, tattoo, or anything on the face which might interfere with the evaluation
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
• Subject in a social or sanitary establishment
• Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study (for France only)
• In terms of associated pathology:
• Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
• Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device
• Subject with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation
• Subject with a tendency to develop keloids or hypertrophic scars
• Relating to previous or ongoing treatment:

Sponsors & Collaborators

• Laboratoires Vivacy: lead
• Avania B.V.: collaborator
• Canfield Scientific Inc.: collaborator

Study Sites (1)

Centre Medical Saint Jean

Arras, France

Location

Study Officials

• Hervé RASPALDO, MD

  Private Clinic, GENEVA, SWITZERLAND

  PRINCIPAL INVESTIGATOR

• Hugues CARTIER, MD

  Centre Medical Saint-Jean, ARRAS, FRANCE

  PRINCIPAL INVESTIGATOR

• Thomas RAPPL, MD

  Medical Aesthetic Research Academy, GRAZ, AUSTRIA

  PRINCIPAL INVESTIGATOR

• Cyril CLERICO, MD

  Private Practice, NICE, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary endpoint is assessed through objective measures of facial volume, obtained using standardized, three-dimensional (3D), digital photographic images. Measurement will be made by an independent expert who will be blinded, as image files will not reveal subject treatment randomization, or the time point at which the image was taken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-Center, Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the STYLAGE® XXL (treatment) arm or the no-treatment control arm. After 24 weeks, the no-treatment control arm (delayed treatment group) will receive their first treatment and will then follow the same schedule as the initial treatment group. After the no-treatment control group receives treatment, data from both groups will be pooled.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 2, 2022
• Study Start: June 6, 2022
• Primary Completion: May 15, 2024
• Study Completion: April 25, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)