Clinical Performance and Safety of STYLAGE® HydroMax

Официальное название

A Prospective, Multicentric, Randomized, Evaluator-blind, Controlled, Interventional Clinical Investigation Evaluating the Clinical Performance and Safety of STYLAGE® HydroMax, a Hyaluronic Acid-based Gel

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство STYLAGE® HydroMax
  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)

Первичные конечные точки

• Mean changes in cheek wrinkle score (independant blinded evaluator) [Срок оценки: 6 weeks port-baseline]

Вторичные конечные точки (12)

• Mean changes in cheek wrinkle score (live assessments) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From pre-treatment baseline to 6 and 36 weeks post treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Eurofins DERMSCAN — Aix-en-Provence
• Eurofins DERMSCAN PHARMASCAN — Villeurbanne

Идентификаторы

NCT: NCT07153237 · VIV-STYL-HYDM-02 · 2025-A00467-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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