Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity

Официальное название

A Prospective Clinical Investigation Evaluating the Safety and Effectiveness of FASY L Hyaluronic Acid Gel for the Treatment of Lip Deformity

Обзор

Early postnatal repair of cleft lip and palate aims at the development of the child through reconstruction of the face soon after birth. Cleft lip is the result of a defect in the fusion of the buds of the face by default of cell apoptosis of the embryonic neural crest constituting the skin and the labial mucosa. Lip surgery or cheiloplasty primary of unilateral and bilateral cleft lip and palate is carried out from the age of 6 weeks. At the end of the surgical treatment, we often observe small unsightly residual volumetric asymmetries. The choice is then either to surgically reduce a muscular part too voluminous by reducing locally the volume of the lip, or to increase the volume of the thinnest portion this second solution is made possible either by injecting fat or by injection of hyaluronic acid. By adulthood, patients with cleft lip have often undergone 10 or more defect-related surgeries and many desire less invasive options to improve any residual cosmetic imperfections. The first use of a temporary alloplastic injectable soft tissue filler, hyaluronic acid (HA), for upper lip augmentation in a patient with asymmetry after surgical cleft lip repair was reported in 2008. There are few publications on the use hyaluronic acid in complement to the surgical treatment of cleft lip and palate, but all reported promising results.

Подробное описание

The study is a pilot, prospective, multicenter, proof-of-concept clinical trial that aims to evaluate the safety and efficacy of FASY L for the treatment of lip deformity.

Вмешательства

• Устройство FASY L
  Subjects will receive FASY L in lips at level of their scar.

Первичные конечные точки

• Proportion of subjects with at least one Adverse Device Event (ADE) at the visit at 30 days after the initial injection [Срок оценки: 30 days visit after the first injection]

Вторичные конечные точки (9)

• Injection Site Reactions present immediatly after injections [Срок оценки: Day 0 and potentially at each visits (Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection)]
• Evaluation of the scar by the investigators [Срок оценки: Before the first injection (baseline) and Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection]
• Evaluation of the scar by the patients [Срок оценки: Before the first injection (baseline) and Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.]
• Patient Global aesthetic improvement [Срок оценки: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.]
• Investigator Global aesthetic improvement [Срок оценки: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.]
• Patient's quality of life [Срок оценки: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.]
• Improvement of the patient's quality of life [Срок оценки: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.]
• Visual analogic scale pain assessment [Срок оценки: Immediately after the injection (for initial injection only)]

Критерии участия

Критерии включения

• Sex: male or female.
• Age: 18 years and older.
• Women of childbearing age must have a negative urine pregnancy test before each injection.
• Patient seeking an enhancement of the lip deformity with FASY L after having undergone cleft lip and palate surgical treatment.
• Patient, having given freely and expressly his/her informed consent.
• Patient who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
• Patient being affiliated to a health social security system.

Критерии исключения

• Pregnant and breastfeeding women
• Subject who is deprived of their freedom by administrative or legal decision.
• Subject living in a social or sanitary establishment.
• Major subject who is under guardianship or who is not able to express his consent.
• Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria.
• Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock.
• Subject with a known allergy or hypersensitivity to Hyaluronic Acid or local anesthesia (Lidocaine or anesthetics of the amide type or any of the excipients).
• Subject with an acute inflammatory process or active skin disease, or related conditions, such as infection, psoriasis, rosacea, acne, blotches or other pathology near or on the injection sites with the potential to interfere with the study results or increase the risk of Adverse Events at the Investigator appreciation.
• Subject with a past history of severe streptococcal disease or an active streptococcus infection.
• Subject predisposed to keloid or hypertrophic scarring.
• Subject with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
• Subject with a history of precancerous lesions/skin malignancies on the injection sites.
• Subject with history of hyper- or hypo-pigmentation on the face.
• Subject with a known bleeding disorder or receiving medication that will likely increase the risk of bleeding during treatment, at the Investigator appreciation.
• Subject having received high dose of Lidocaine (more than 200mg) and/or high dose of anesthetics structurally related to amide-type within the past week.
• Subject having received chemotherapy agents, immunosuppressive medications or systemic corticosteroids within the past 3 months.
• Patient having taken high-dose aspirin, anti-inflammatories, antiplatelet, thrombolytic during the week before the injection session.
• Subject having received within the past 12 months any injections including non-permanent fillers (e.g., Hyaluronic Acid, CaHA), mesotherapy or neurotoxin near or on the lips or plan to undergo such treatment during the study.
• Subject with prior permanent implant or treatment with non-HA or non-collagen filler near or on the lip or plan to implement these products at any time during the study.
• Subject having received within the past 6 months mesotherapy, resurfacing laser, photo modulation, intense pulsed light, radio frequency, photo-rejuvenation, dermabrasion, chemical peel, or other ablative or none ablative procedures near or on the lips.
• Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand etc.) near or on the injection sites (lips) with the potential to interfere with the study results or increase the risk of Adverse Events at the Investigator appreciation.
• Patient having received fat grafting within the past 6 months near or on the injection sites
• Other condition preventing the subject to participate the study in the Investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.
• Subject who planned an intensive exposure to sunlight or UV-rays in the 2 weeks following injection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Hôpital Roger Salengro — Lille
• Cabinet médical — Toulouse
• Cabinet médical — Paris

Идентификаторы

NCT: NCT05825170 · CLIN2202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗