Not Yet RecruitingNot Applicable

Clinical Performance and Safety of STYLAGE® HydroMax

France81 participantsStarted 2025-09-09

Plain-language 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.

Who can participate

Age range35 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Mean changes in cheek wrinkle score (independant blinded evaluator)

Timeframe: 6 weeks port-baseline

Trial details

NCT IDNCT07153237

SponsorLaboratoires Vivacy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Audrey TROUILLOUD, PhD

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

View on ClinicalTrials.gov More Aging trials