AgingFHAMENCT07153237
Clinical Performance and Safety of STYLAGE® HydroMax
A study testing STYLAGE® HydroMax in people with Aging and Aesthetic, run by Laboratoires Vivacy at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- What is being tested?
- STYLAGE® HydroMax
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Sep 2025to 9 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects without any pathology aged between 35 and 70 years old at inclusion.
- 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.
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- 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.
Who cannot join
- 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.
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- 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 participating in another research on human beings or who is in an exclusion period of one.
- 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 suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes in the midface area is eligible if asymptomatic at time of inclusion.
- 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.
- Subject who had dental surgery within the 6 weeks prior to the start of the investigation.
- Subject having received treatment with laser, dermabrasion, surgery, deep chemical peeling, or other ablative procedure on the investigated areas within the 12 months prior to start of the investigation.
- Subject having received injections of botulinum toxin within the 9 months prior to the start of the investigation.
- Subject having received an injection with a resorbable filling product in the investigated areas within the 18 months prior to the start of the investigation.
- Subject having previously received at any time in the past 24 months an injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of HA and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate…) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles …).
- Subject having previously received at any time in the past 24 months a treatment with tensor threads on the face.
- Subject having taken medication such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, naproxen…), antiplatelet agents, anticoagulants, vitamin C in the week prior each injection session or who is a chronic user of these medications.
- Subject undergoing a topical treatment on the test areas or taking either of the following systemic treatments:
- Antihistamines within the 2 weeks prior to the start of the investigation.
- Immunosuppressors and/or corticoids within the 4 weeks prior to the start of the investigation.
- Retinoids within the 6 months prior to the start of the investigation
Trial locations and contacts
2 sites in 1 country.
France2 sites
Eurofins DERMSCAN
Aix-en-Provence, 13290
Eurofins DERMSCAN PHARMASCAN
Villeurbanne, 69100
About this study
Official title: A Prospective, Multicentric, Randomized, Evaluator-blind, Controlled, Interventional Clinical Investigation Evaluating the Clinical Performance and Safety of STYLAGE® HydroMax, a Hyaluronic Acid-based Gel
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.
Read the detailed description
FHAME is an interventional, post-market, multicentric, prospective, randomized clinical investigation conducted in subjects without any pathology, treated with CE-marked STYLAGE® HydroMax to confirm and update its clinical performance and safety. The primary objective of the study is to assess the mean change from baseline in cheek wrinkle severity, evaluated by an independent blinded assessor at six weeks post-baseline using the Bazin cheek wrinkle scale during live assessments. Clinical performance will be demonstrated if the mean change in the Bazin cheek wrinkle score at six weeks post-baseline is statistically superior in the treatment group (Group A) compared to the control group (Group B). To demonstrate the superiority of STYLAGE® HydroMax compared to no treatment, a total of 81 subjects will be randomized in the study. The overall duration of the study is expected to be approximately seventeen months, including a recruitment period of around six months, a screening period of two weeks, and an investigation period of thirty-six weeks post-randomization for Group A and forty-two weeks for Group B.
- Being tested
- STYLAGE® HydroMax
- Keywords
- Hyaluronic Acid, Aging, Aesthetics, Healthy subjects, Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLAGE® HydroMaxDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: STYLAGE® HydroMax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks port-baseline
Secondary outcomes (22)
Mean changes in cheek wrinkle score (live assessments)
Mean changes in cheek wrinkle score assessed using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) during live assessments:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no-treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis.
Measured: 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)
Percentages of improved subjects, assessed using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) during live assessments:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no-treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis.
Measured: 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)
Mean changes in cheek wrinkle score assessed using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) by central review: From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b). From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment.
Measured: 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)
Percentages of improved subjects, assessed using the 8-grade Bazin cheek wrinkle scale (0 = no wrinkles, 8 = most severe wrinkles) by central review:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment.
Measured: 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)
Mean changes in crow's feet wrinkle score assessed using the 6-grade Bazin crow's feet wrinkle scale (0 = no wrinkles, 6 = most severe wrinkles) during live assessments:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no-treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 crow's feet wrinkle score (live assessments)
Percentages of improved subjects, assessed using the 6-grade Bazin crow's feet wrinkle scale (0 = no wrinkles, 6 = most severe wrinkles) during live assessments:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no-treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 crow's feet wrinkle score (central review)
Mean changes in crow's feet wrinkle score assessed using the 6-grade Bazin crow's feet wrinkle scale (0 = no wrinkles, 6 = most severe wrinkles) by central review:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment
Measured: From baseline to 3 and 6 weeks post-baseline. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement
Percentages of improved subjects in crow's feet wrinkle score (central review)
Percentages of improved subjects, assessed using the 6-grade Bazin crow's feet wrinkle scale (0 = no wrinkles, 6 = most severe wrinkles) by central review:
From baseline (V1a/V1b) to 3 weeks post-baseline (V2a/V2b and 6 weeks (V3a/V3b) post-baseline.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment.
Measured: 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 cheek and crow's feet wrinkle volume (3D photography)
Mean changes in cheek and crow's feet wrinkle volume determined by central analysis of 3D photography:
From baseline (V0 or V1a/V0 or V1b) to 3 weeks (V2a/V2b) and 6 weeks post-baseline (V3a/V3b), for the "no-treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 and crow's feet wrinkle depth (3D photography)
Mean changes in cheek and crow's feet wrinkle depth determined by central analysis of 3D photography: From baseline (V0 or V1a/V0 or V1b) to 3 weeks (V2a/V2b) and 6 weeks post-baseline (V3a/V3b), for the "no-treatment" controlled stage analysis. From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 cutaneous roughness of the crow's feet and cheek (3D photography)
Mean changes in cutaneous roughness of the crow's feet and cheek areas determined by central analysis of 3D photography:
- From baseline (V0 or V1a/V0 or V1b) to 3 weeks (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no-treatment" controlled stage analysis.
- From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis.
Measured: 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 cutaneous tension of the crow's feet and cheek (3D photography)
Mean changes in cutaneous tension of the crow's feet and cheek areas determined by central analysis of 3D photography:
From pre-treatment baseline (V0 or V1a/V3b) to 6 weeks (V3a/V5b), and 36 weeks (V6a/V8b) post treatment, for the final analysis.
Measured: From pre-treatment baseline to 6 and 36 weeks post treatment
Mean changes in skin thickness of the crow's feet and cheek (DermaScan C USB)
Mean changes in skin thickness of the crow's feet and cheek areas determined using DermaScan C USB, a high frequency skin ultrasound used to visualize layers of the skin and subcutaneous tissues and to make approximate dimensional measurements:
From baseline (V1a/V1b) to 3 weeks (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 density of the crow's feet and cheek (DermaScan C USB)
Mean changes in density of the crow's feet and cheek areas determined using DermaScan C USB, a high frequency skin ultrasound used to visualize layers of the skin and subcutaneous tissues and to make approximate dimensional measurements: From baseline (V1a/V1b) to 3 weeks (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no treatment" controlled stage analysis. From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis
Measured: 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 GAIS responders, assessed by the subject and the Evaluator
Percentages of GAIS (Global Aesthetic Improvement Scale, rated on a 5-point scale) responders, assessed by the subject and the Evaluator:
At 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post-treatment
Measured: At 3, 6, 12, 24 and 36 weeks post-treatement
Mean changes in subject's satisfaction scores for cheeks and crow's feet (FACE-Q)
Mean changes in subject's satisfaction scores for cheeks and crow's feet treatment using the FACE-Q TM "Satisfaction with Skin", FACE-QTM "Satisfaction with Cheeks", FACE-QTM"Appraisal of Lines: Crow's feet", and FACE-QTM "Patient perceived age visual analogue scale" questionnaires (Rasch transformed score):
From baseline (V1a/V1b) to 3 weeks (V2a/V2b) and 6 weeks (V3a/V3b) post-baseline, for the "no treatment" controlled stage analysis.
From pre-treatment baseline (V1a/V3b) to subsequent visits at 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post treatment, for the final analysis.
Measured: 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 subjects who are satisfied and percentages of subjects for whom the Evaluator is satisfied for each item (satisfaction questionnaire)
Percentages of subjects who are satisfied and percentages of subjects for whom the Evaluator is satisfied for each item of the satisfaction questionnaire (6-point sale):
At 3 weeks (V2a/V4b), 6 weeks (V3a/V5b), 12 weeks (V4a/V6b), 24 weeks (V5a/V7b), and 36 weeks (V6a/V8b) post-treatment.
Measured: At 3, 6, 12, 24 and 36 weeks post-treatement
Mean pain scores during injection assessed by subject (10-cm visual analogue scale)
Mean pain scores during injection assessed by subject using a 10-cm visual analogue scale (VAS) ranging from 0 ("no pain at all") to 10 ("unbearable pain"):
Within 5 minutes of the injections performed at the first injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b)
Measured: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b)
Percentages of subjects for whom the Treating Investigators are satisfied of the usability of the device
Percentages of subjects for whom the Treating Investigators are satisfied with the usability of the device for each item of the questionnaire, assessed using six 10-point scale questions evaluating the usability of the HA gel in each area:
Within 10 minutes after performing the injections at the first injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Measured: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Percentages of subjects for whom the Treating Investigators are satisfied with the ease of massaging
Percentages of subjects for whom the Treating Investigators are satisfied with the ease of massaging, assessed using a 5-point scale for each area of the HA gel:
Within 10 minutes after performing the injections at the first injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Measured: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Occurrence of Injection Site Reactions (ISRs) to Assess Product Safety and Tolerability
Product safety and tolerance will be assessed by collection of the occurence of any Injection site reactions (ISRs).
The following events occurring within 14 days after an injection session will be considered as ISR: redness/erythema, pain/tenderness, burning sensation, firmness/induration, sensitivity disorder, swelling/edema, lumps/bumps, bruising/ecchymosis with potential bleeding and hematoma, itching.
An ISR can be requalified as an adverse event (AE) if, at the discretion of the principal investigator, the nature of the observation/event exceeds what would be expected and considered normal.
Measured: Throughout the investigation period: V0, V1a/V1b, V2a/V2b, V3a/V3b, V4a/V4b, V5a/V5b, V6a/V6b, V7b, V8b
Occurrence of Adverse Events (AE) to Assess Product Safety and Tolerability
Product safety and tolerance will be assessed by collection of the occurence of any Adverse Events (AE).
Any other events occurring at any time or any ISR (Injection Site Reaction) persisting beyond 14 days after an injection session will be considered an AE.
Measured: Throughout the investigation period: V0, V1a/V1b, V2a/V2b, V3a/V3b, V4a/V4b, V5a/V5b, V6a/V6b, V7b, V8b
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start9 Sep 2025
- Primary completion2 Mar 2026
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quantificare SA, Eurofins Dermscan Pharmascan, Inferential, International Clinical Trials Association
- Responsible party
- Sponsor
- Investigators
- Patricia MOREL-MANDRINO, MD, Principal investigator, Eurofins Dermscan, Villeurbanne, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153237
- Sponsor's protocol ID
- VIV-STYL-HYDM-02
- Other IDs
- 2025-A00467-42
- Acronym
- FHAME
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Randomized, Evaluator-blind, Controlled, Interventional Clinical Investigation Evaluating the Clinical Performance and Safety of STYLAGE® HydroMax, a Hyaluronic Acid-based Gel
- ClinicalTrials.gov ID
- NCT07153237
- Acronym / sponsor ID
- FHAME / VIV-STYL-HYDM-02
- Keywords
- Hyaluronic Acid, Aging, Aesthetics, Healthy subjects, Injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Collaborators
- Quantificare SA, Eurofins Dermscan Pharmascan, Inferential, International Clinical Trials Association
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FHAME is an interventional, post-market, multicentric, prospective, randomized clinical investigation conducted in subjects without any pathology, treated with CE-marked STYLAGE® HydroMax to confirm and update its clinical performance and safety. The primary objective of the study is to assess the mean change from baseline in cheek wrinkle severity, evaluated by an independent blinded assessor at six weeks post-baseline using the Bazin cheek wrinkle scale during live assessments. Clinical performance will be demonstrated if the mean change in the Bazin cheek wrinkle score at six weeks post-baseline is statistically superior in the treatment group (Group A) compared to the control group (Group B). To demonstrate the superiority of STYLAGE® HydroMax compared to no treatment, a total of 81 subjects will be randomized in the study. The overall duration of the study is expected to be approximately seventeen months, including a recruitment period of around six months, a screening period of two weeks, and an investigation period of thirty-six weeks post-randomization for Group A and forty-two weeks for Group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention Arm (Group A): two injection sessions with STYLAGE® HydroMax before Week 6 | Experimental | Device: STYLAGE® HydroMaxSubjects 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. |
| Control Arm (Group B): No Treatment before Week 6 | Other | Device: STYLAGE® HydroMaxSubjects 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects without any pathology aged between 35 and 70 years old at inclusion.
- 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).
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STYLAGE® HydroMax3 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) | Device | Active Intervention Arm (Group A): two injection sessions with STYLAGE® HydroMax before Week 6, Control Arm (Group B): No Treatment before Week 6 |
Primary outcome
Mean changes in cheek wrinkle score (independant blinded evaluator)
Time frame: 6 weeks port-baseline
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.
22 secondary outcomes
Mean changes in cheek wrinkle score (live assessments)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 crow's feet wrinkle score (live assessments)
Time frame: 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 crow's feet wrinkle score (central review)
Time frame: From baseline to 3 and 6 weeks post-baseline. From pre-treatment baseline to 3, 6, 12, 24 and 36 weeks post-treatement
Percentages of improved subjects in crow's feet wrinkle score (central review)
Time frame: 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 cheek and crow's feet wrinkle volume (3D photography)
Time frame: 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 and crow's feet wrinkle depth (3D photography)
Time frame: 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 cutaneous roughness of the crow's feet and cheek (3D photography)
Time frame: 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 cutaneous tension of the crow's feet and cheek (3D photography)
Time frame: From pre-treatment baseline to 6 and 36 weeks post treatment
Mean changes in skin thickness of the crow's feet and cheek (DermaScan C USB)
Time frame: 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 density of the crow's feet and cheek (DermaScan C USB)
Time frame: 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 GAIS responders, assessed by the subject and the Evaluator
Time frame: At 3, 6, 12, 24 and 36 weeks post-treatement
Mean changes in subject's satisfaction scores for cheeks and crow's feet (FACE-Q)
Time frame: 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 subjects who are satisfied and percentages of subjects for whom the Evaluator is satisfied for each item (satisfaction questionnaire)
Time frame: At 3, 6, 12, 24 and 36 weeks post-treatement
Mean pain scores during injection assessed by subject (10-cm visual analogue scale)
Time frame: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b)
Percentages of subjects for whom the Treating Investigators are satisfied of the usability of the device
Time frame: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Percentages of subjects for whom the Treating Investigators are satisfied with the ease of massaging
Time frame: First injection session (V1a/V3b), the second injection session (V2a/V4b) and the third injection session (V5a/V7b).
Occurrence of Injection Site Reactions (ISRs) to Assess Product Safety and Tolerability
Time frame: Throughout the investigation period: V0, V1a/V1b, V2a/V2b, V3a/V3b, V4a/V4b, V5a/V5b, V6a/V6b, V7b, V8b
Occurrence of Adverse Events (AE) to Assess Product Safety and Tolerability
Time frame: Throughout the investigation period: V0, V1a/V1b, V2a/V2b, V3a/V3b, V4a/V4b, V5a/V5b, V6a/V6b, V7b, V8b
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia MOREL-MANDRINO, MD principal investigator
Eurofins Dermscan, Villeurbanne, FRANCE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STYLAGE® HydroMax in people with Aging and Aesthetic, run by Laboratoires Vivacy at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in cheek wrinkle score (independant blinded evaluator) (time frame: 6 weeks port-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.