Actively Recruiting
Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity
Led by Symatese · Updated on 2025-03-13
20
Participants Needed
3
Research Sites
183 weeks
Total Duration
On this page
Sponsors
S
Symatese
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18 years or older
- Women of childbearing age must have a negative urine pregnancy test before each injection
- Seeking lip enhancement with FASY L after cleft lip and palate surgery
- Able to provide informed consent
- Able to comply with study requirements
- Affiliated with a health social security system
You will not qualify if you...
- Pregnant or breastfeeding women
- Legally or administratively deprived of freedom
- Living in social or healthcare institutions
- Under guardianship or unable to consent
- Participating or recently participated (<3 months) in another investigational drug/device study
- Having severe or progressive diseases like diabetes, autoimmune diseases, cardiac issues, liver deficiency, epilepsy, or porphyria
- History of severe allergies, angioedema, or anaphylactic shock
- Allergic to hyaluronic acid or local anesthetics
- Active inflammatory skin conditions or infections near injection sites
- Past severe streptococcal disease or current streptococcus infection
- Prone to keloid or hypertrophic scars
- Disorders affecting wound healing
- History of precancerous or malignant skin lesions on injection sites
- History of facial pigmentation disorders
- Known bleeding disorders or on medications increasing bleeding risk
- Recent high doses of lidocaine or related anesthetics
- Recent chemotherapy, immunosuppressive drugs, or systemic corticosteroids (<3 months)
- Recent use of high-dose aspirin, anti-inflammatories, antiplatelets, or thrombolytics (<1 week)
- Recent injections or plans for non-permanent fillers or neurotoxins near lips (<12 months)
- Prior permanent or non-HA/non-collagen fillers near lips or plans for such treatments
- Recent cosmetic procedures near lips (<6 months)
- Presence of facial subcutaneous structures like threads or gold strands near injection sites
- Recent fat grafting near injection sites (<6 months)
- Other conditions judged by investigator to prevent participation
- Planned intensive sun or UV exposure within 2 weeks post-injection
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hôpital Roger Salengro
Lille, Nord, France, 59037
Actively Recruiting
2
Cabinet médical
Toulouse, Occitanie, France, 31400
Actively Recruiting
3
Cabinet médical
Paris, Île-de-France Region, France, 75007
Actively Recruiting
Research Team
L
Laure Saillet
CONTACT
J
Justine Colombel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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