Using a hyaluronic acid filler to improve lip deformities
A Prospective Clinical Investigation Evaluating the Safety and Effectiveness of FASY L Hyaluronic Acid Gel for the Treatment of Lip Deformity
This study is testing a new lip filler to see if it can help adults with leftover lip deformities from cleft lip and palate surgery look and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Symatese Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Lille, Nord and 2 other locations) |
| Trial ID | NCT05825170 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the safety and efficacy of FASY L, a hyaluronic acid dermal filler, for enhancing lip deformities in patients who have previously undergone surgical treatment for cleft lip and palate. The study involves a multicenter approach, enrolling participants who are 18 years or older and seeking non-invasive options to address residual cosmetic imperfections. Participants will receive injections of FASY L and will be monitored for outcomes related to both safety and aesthetic improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone surgical treatment for cleft lip and palate and are seeking enhancement of their lip deformity.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients to improve the appearance of their lips after cleft lip surgery.
How similar studies have performed: Other studies have shown success with similar approaches using hyaluronic acid fillers for cosmetic enhancements, indicating a promising avenue for this treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Lille, Nord and 2 other locations
- Hôpital Roger Salengro — Lille, Nord, France (Recruiting)
- Cabinet médical — Toulouse, Occitanie, France (Recruiting)
- Cabinet médical — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Cyril Maire — Centre Médical Saint-Jean
- Study coordinator: Laure Saillet
- Email: laure.saillet@evamed.fr
- Phone: (0)2 31 93 21 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.