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

NCT05825170 | Recruiting DMC

• 1 other identifier: CLIN2202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lip, Cleft; Lip Scar

Keywords

Hyaluronic acid; Dermal fillers; lips

Outcome Measures

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.

  30 days visit after the first injection

Secondary Outcomes (9)

• Injection Site Reactions present immediatly after injections

  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

  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

  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

  Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.

• Patient Global aesthetic improvement

  Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.

Study Arms (1)

FASY L

EXPERIMENTAL

Subjects will be consecutively included to receive FASY L in lips at level of their scar

Device: FASY L

Interventions

FASY L DEVICE

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

FASY L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Symatese: lead
• EVAMED: collaborator

Study Sites (3)

Hôpital Roger Salengro

Lille, Nord, 59037, France

RECRUITING

Cabinet médical

Toulouse, Occitanie, 31400, France

RECRUITING

Cabinet médical

Paris, Île-de-France Region, 75007, France

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cyril Maire

  Centre Médical Saint-Jean

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Saillet

CONTACT

(0)2 31 93 21 18; laure.saillet@evamed.fr

Justine Colombel

CONTACT

(0)2 31 93 21 18; justine.colombel@evamed.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: December 8, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)