Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face (FaceHyal)

NCT05747456 | Completed

• 1 other identifier: VIV-IPN-21-SENSE-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE 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)

IPN-21-SENSE Treatment Group

EXPERIMENTAL

Subjects randomized (5:1 ratio) to receive an initial treatment with IPN-21-SENSE 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.

Device: IPN-21-SENSE

No-Treatment Control Group, then Delayed Treatment with IPN-21-SENSE

OTHER

No-Treatment for the first 6-month, then subjects will receive a delayed treatment with IPN-21-SENSE 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.

Device: IPN-21-SENSE

Interventions

IPN-21-SENSE 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.

IPN-21-SENSE Treatment Group

Eligibility Criteria

• Age: 30 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 30 and 84 years.
• Seeking correction of the mid-face volume deficit, and agrees with the recommendation of 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.

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 Mid-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 4,500 Euros in indemnities for participation in research involving human beings in France in the past 12 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 with any history of healing disorders.
• Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to lidocaine, or to antiseptic solution or any other amide type local anaesthetics.
• Subject presenting a history of severe, evolutive, unstable, or recent allergies.
• Subject suffering from porphyria.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (1)

Eurofins Dermscan

Villeurbanne, France

Location

Study Officials

• Patricia MOREL-MANDRINO, MD

  Eurofins Dermscan, Villeurbanne, 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: Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the IPN-21-SENSE (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: February 17, 2023
• First Posted: February 28, 2023
• Study Start: February 22, 2023
• Primary Completion: April 30, 2024
• Study Completion: September 2, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)