Status:
NOT_YET_RECRUITING
Clinical Performance and Safety of STYLAGE® HydroMax
Lead Sponsor:
Laboratoires Vivacy
Collaborating Sponsors:
Quantificare SA
Eurofins Dermscan Pharmascan
Conditions:
Aging
Aesthetic
Eligibility:
All Genders
35-70 years
Phase:
NA
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 ...
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 a...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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 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
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07153237
Start Date
September 9 2025
End Date
November 1 2026
Last Update
September 10 2025
Active Locations (2)
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1
Eurofins DERMSCAN
Aix-en-Provence, France, 13290
2
Eurofins DERMSCAN PHARMASCAN
Villeurbanne, France, 69100