Clinical Performance and Safety of STYLAGE® HydroMax

NCT07153237 | Not Yet Recruiting

• 2 other identifiers: VIV-STYL-HYDM-022025-A00467-42
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

FHAME is a post-market clinical investigation designed to strengthen the clinical evidence supporting the effectiveness of STYLAGE® HydroMax in the treatment of superficial wrinkles, primarily on the cheeks.

Conditions

Aging; Aesthetic

Keywords

Hyaluronic Acid; Aging; Aesthetics; Healthy subjects; Injection

Outcome Measures

Primary Outcomes (1)

• Mean changes in cheek wrinkle score (independant blinded evaluator)

  Mean change from baseline in cheek wrinkle severity score assessed by an independent blinded evaluator at 6 weeks (V3a/V3b) post-baseline using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) during live assessments.

  6 weeks port-baseline

Secondary Outcomes (22)

• Mean changes in cheek wrinkle score (live assessments)

  From baseline to 3 and 6 weeks post-baseline for the "no-treatment" controlled stage analysis. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement for the final analysis

• Percentages of improved subjects in cheek wrinkle score (live assessments)

  From baseline to 3 and 6 weeks post-baseline for the "no-treatment" controlled stage analysis. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement for the final analysis

• Mean changes in cheek wrinkle score (central review)

  From baseline to 3 post-baseline and from pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement for the final analysis

• Percentages of improved subjects in cheek wrinkle score (central review)

  From baseline to 3 and 6 weeks post-baseline. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement.

• Mean changes in crow's feet wrinkle score (live assessments)

  From baseline to 3 and 6 weeks post-baseline for the "no-treatment" controlled stage analysis. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement for the final analysis

Study Arms (2)

Active Intervention Arm (Group A): two injection sessions with STYLAGE® HydroMax before Week 6

EXPERIMENTAL

Subjects will be randomized 2:1 to Group A. During Stage 1, they will receive two STYLAGE® HydroMax injection sessions at baseline and Week 3. In Stage 2, they will be followed for 30 additional weeks (up to Week 36) and will receive a third injection at Week 24 after the first injection.

Device: STYLAGE® HydroMax

Control Arm (Group B): No Treatment before Week 6

OTHER

Subjects will be randomized 2:1 to Group B. In Stage 1, they will receive no treatment until Week 6. Data collected at Week 6 will serve as pre-treatment baseline. In Stage 2, eligible subjects in Group B will receive STYLAGE® HydroMax following the same schedule as Group A. All subjects in Group B will be followed up to 36 weeks after their first STYLAGE® HydroMax injection.

Device: STYLAGE® HydroMax

Interventions

STYLAGE® HydroMax DEVICE

3 injection sessions : Group A: at week 0 (V1a), week 3 (V2a), and week 24 (V5a). Group B: at week 6 (V3b), week 3 from V3b (V4b), and week 24 from V3b (V7b)

Active Intervention Arm (Group A): two injection sessions with STYLAGE® HydroMax before Week 6; Control Arm (Group B): No Treatment before Week 6

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects wishing treatment for the aesthetic improvement of facial wrinkles.
• Subject having given freely and expressly their informed consent.
• Subject with a Grade 2 to 5 score on the Bazin cheek wrinkle scale.
• Subject with the same wrinkle score according to the Bazin cheek wrinkle scale for both cheeks (i.e., symmetrical cheeks).
• Subject psychologically able to understand investigation related information and to give written informed consent.
• Subject affiliated to a health social security system.
• Female of childbearing potential must use a medically accepted contraceptive regimen for at least 12 weeks prior to the start of the investigation and for the duration of the investigation.
• Subject agreeing not to change any hormonal treatment (including contraceptive treatment and hormone replacement therapy) for the duration of the investigation.
• Subject agreeing to keep their usual cleansing / care products for the duration of the investigation.
• Subject agreeing to apply a SPF50 cream when exposed to non-intensive sunlight (i.e., excluding prolonged sun exposure such as sunbathing or extended beach exposure).
• Subject able to comply with investigation requirements and complete all required visits.
• Subject agreeing not to receive any other plastic surgery or cosmetic procedure on the face (e.g. dermal fillers, toxin-based treatment, fractional or ablative laser, micro-dermabrasion, chemical peel, noninvasive procedures for skin laxity) for the duration of the investigation.
• Subject agreeing not to have any planned dental surgery during the investigation.

You may not qualify if:

• Pregnant or breastfeeding woman or woman planning a pregnancy during the investigation.
• Woman less than a year past menopause.
• Subject with a tattoo, a scar, moles, too many hairs or body hairs (i.e. beard), or anything on the studied zones which might interfere with outcome evaluations.
• Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Member of the investigating team or family member of a member of the investigating team.
• Subject in a social or sanitary establishment.
• Subject having received 6000 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present investigation.
• Subject who had intensive exposure to sunlight (i.e., prolonged sun exposure such as sunbathing or extended beach exposure) or UV-rays within the previous month and/or for whom intensive exposure to sunlight or UV-rays is foreseen during the clinical investigation.
• Subject suffering from severe or progressive disease or any other pathology that may interfere with the evaluation of the investigation results.
• Subject with known history of, or suffering from, autoimmune disease and/or immune deficiency.
• Subject having a history of severe allergy or anaphylactic shock including hypersensitivity to HA or to one of the components of the tested device, to antiseptic solution or anesthesia products if applicable.
• Subject with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
• Subject predisposed to keloids or hypertrophic scarring.
• Subject prone to develop inflammatory skin conditions or has a tendency to bleeding disorders.
• Subject with a fructose intolerance.

Sponsors & Collaborators

• Laboratoires Vivacy: lead
• Quantificare SA: collaborator
• Eurofins Dermscan Pharmascan: collaborator
• Inferential: collaborator
• International Clinical Trials Association: collaborator

Study Sites (2)

Eurofins DERMSCAN

Aix-en-Provence, 13290, France

Location

Eurofins DERMSCAN PHARMASCAN

Villeurbanne, 69100, France

Location

Study Officials

• Patricia MOREL-MANDRINO, MD

  Eurofins Dermscan, Villeurbanne, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey TROUILLOUD, PhD

CONTACT

+33 4 50 31 71 81; a.trouilloud@vivacy.fr

Claire BARBIERI, PharmD

CONTACT

+33 4 50 31 71 81; c.barbieri@vivacy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 3, 2025
• Study Start: September 9, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)