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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive FASY L in lips at level of their scar.
Hôpital Roger Salengro
Lille, Nord, France
RECRUITINGCabinet médical
Toulouse, Occitanie, France
RECRUITINGCabinet médical
Paris, Île-de-France Region, France
RECRUITINGProportion of subjects with at least one Adverse Device Event (ADE) at the visit at 30 days after the initial injection
Recording of the occurrence of Adverse Event related to the use of the investigational medical device. Assessed by investigators.
Time frame: 30 days visit after the first injection
Injection Site Reactions present immediatly after injections
Recording of the presence and severity (mild, moderate or severe) of local injection site reactions after each injection.
Time frame: 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
Assessement of the scar using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS of the observer includes six parameters (vascularity, pigmentation, thickness, relief, elasticity and surface). In addition, a general opinion is scored. Each parameter is rated by the investigator on a scale from 1 ("normal skin") to 10 ("worst scar imaginable"). The sum of the seven parameters constitutes the total score of the scale of the observer ranging from 7 (normal skin) to 70 (worst scar imaginable).
Time frame: 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
Assessement of the scar using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS ot the patient includes six questions about pain, itching, color, roughness, thickness and irregularities of the scar. In addition, a general opinion is scored. Each parameter is rated by the patient on a scale from 1 ("no, not at all") to 10 ("yes, extremely"). The sum of the seven parameters constitutes the total score of the scale of the patients ranging from 7 (normal skin) to 70 (worst scar imaginable)..
Time frame: 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
Collection of Adverse Event assessed and recorded by investigators.
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Patient Global aesthetic improvement
Aesthetic improvement of the face will be assessed using the Global Aesthetic Improvement Scale, a 5-point scale ranking from 1: Very much improved to 5: worse. The lower the score, the better the aesthetic result. Assessed by subjects.
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Investigator Global aesthetic improvement
Aesthetic improvement of the face will be assessed using the Global Aesthetic Improvement Scale, a 5-point scale a 5-point scale ranking from 1: Very much improved to 5: worse. The lower the score, the better the aesthetic result. Assessed by investigators.
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Patient's quality of life
Quality of life will be assessed using Dermatology Life Quality Index (DLQI). The Dermatology Life Quality Index is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease. Assessed by subjects
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Improvement of the patient's quality of life
Improvement will be assessed using a 4-point Likert scale (from 0-not improved to 3-Very much improved). Assessed by subject
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Visual analogic scale pain assessment
Assessment of pain using a 0-100mm Visual Analogue Scale (0 corresponds to no pain and 100 corresponds to the highest pain that can be felt). Assessed by the subject.
Time frame: Immediately after the injection (for initial injection only)
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