Lip, CleftFENTHANCT05825170
Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity
A study testing FASY L in people with Lip, Cleft and Lip Scar, run by Symatese at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lip, Cleft, Lip Scar
- What is being tested?
- FASY L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Dec 2023to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
- 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.
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- 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.
- Subject having received chemotherapy agents, immunosuppressive medications or systemic corticosteroids within the past 3 months.
- Patient having taken high-dose aspirin, anti-inflammatories, antiplatelet, thrombolytic during the week before the injection session.
- Subject having received within the past 12 months any injections including non-permanent fillers (e.g., Hyaluronic Acid, CaHA), mesotherapy or neurotoxin near or on the lips or plan to undergo such treatment during the study.
- Subject with prior permanent implant or treatment with non-HA or non-collagen filler near or on the lip or plan to implement these products at any time during the study.
- Subject having received within the past 6 months mesotherapy, resurfacing laser, photo modulation, intense pulsed light, radio frequency, photo-rejuvenation, dermabrasion, chemical peel, or other ablative or none ablative procedures near or on the lips.
- Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand etc.) near or on the injection sites (lips) with the potential to interfere with the study results or increase the risk of Adverse Events at the Investigator appreciation.
- Patient having received fat grafting within the past 6 months near or on the injection sites
- Other condition preventing the subject to participate the study in the Investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.
- Subject who planned an intensive exposure to sunlight or UV-rays in the 2 weeks following injection.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Roger Salengro
Lille, Nord, 59037
Cyril Maire, 03 20 44 59 62 ext. +33, maire.dermatologie@hotmail.fr
Cyril Maire
- Recruiting
Cabinet médical
Paris, Île-de-France Region, 75007
Laurence Bénouaiche, 01 47 05 36 51 ext. +33, laurence.benouaiche@icloud.com
- Recruiting
Cabinet médical
Toulouse, Occitanie, 31400
Jacques SABOYE, 561538080 ext. +33, dr.saboye@wanadoo.fr
About this study
Official title: A Prospective Clinical Investigation Evaluating the Safety and Effectiveness of FASY L Hyaluronic Acid Gel for the Treatment of Lip Deformity
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.
Read the detailed description
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.
- Conditions
- Lip, Cleft, Lip Scar
- Being tested
- FASY L
- Keywords
- Hyaluronic acid, Dermal fillers, lips
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASY LDevice
Subjects will receive FASY L in lips at level of their scar.
| Study group | Role | What they receive |
|---|---|---|
| FASY L | Experimental | Subjects will be consecutively included to receive FASY L in lips at level of their scar Receives: Device: FASY L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days visit after the first injection
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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)..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Immediately after the injection (for initial injection only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start8 Dec 2023
- Primary completion30 Jan 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip, CleftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symatese
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Cyril Maire, Principal investigator, Centre Médical Saint-Jean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825170
- Sponsor's protocol ID
- CLIN2202
- Acronym
- FENTHA
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Investigation Evaluating the Safety and Effectiveness of FASY L Hyaluronic Acid Gel for the Treatment of Lip Deformity
- ClinicalTrials.gov ID
- NCT05825170
- Acronym / sponsor ID
- FENTHA / CLIN2202
- Conditions
- Lip, Cleft, Lip Scar
- Keywords
- Hyaluronic acid, Dermal fillers, lips
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SymateseIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FASY L | Experimental | Device: FASY LSubjects will be consecutively included to receive FASY L in lips at level of their scar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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 being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASY LSubjects will receive FASY L in lips at level of their scar. | Device | FASY L |
Primary outcome
Proportion of subjects with at least one Adverse Device Event (ADE) at the visit at 30 days after the initial injection
Time frame: 30 days visit after the first injection
Recording of the occurrence of Adverse Event related to the use of the investigational medical device. Assessed by investigators.
9 secondary outcomes
Injection Site Reactions present immediatly after injections
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
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
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
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Patient Global aesthetic improvement
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Investigator Global aesthetic improvement
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Patient's quality of life
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
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the first injection.
Visual analogic scale pain assessment
Time frame: Immediately after the injection (for initial injection only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cyril Maire principal investigator
Centre Médical Saint-Jean
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASY L in people with Lip, Cleft and Lip Scar, run by Symatese at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Saillet ((0)2 31 93 21 18 ext. +33, laure.saillet@evamed.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with at least one Adverse Device Event (ADE) at the visit at 30 days after the initial injection (time frame: 30 days visit after the first injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.