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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Roger Salengro
RECRUITING
Lille
Cabinet médical
RECRUITING
Paris
Cabinet médical
RECRUITING
Toulouse
Contact Information
Primary
Laure Saillet
laure.saillet@evamed.fr
(0)2 31 93 21 18
Backup
Justine Colombel
justine.colombel@evamed.fr
(0)2 31 93 21 18
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 20
Treatments
Experimental: FASY L
Subjects will be consecutively included to receive FASY L in lips at level of their scar
Related Therapeutic Areas
Sponsors
Collaborators: EVAMED
Leads: Symatese

This content was sourced from clinicaltrials.gov