Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSymatese
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
FASY L
DeviceSubjects will receive FASY L in lips at level of their scar.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: FASY LExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion 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 injectionSecondary outcomes
1
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)2
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 injection3
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 injection4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Symatese
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov