Facial Lipoatrophy (FLA)HAtrophyNCT05776836
Evaluation of HA Dermal Fillers in the Treatment of Pathological Facial Lipoatrophy
A study testing Dermal filler in people with Facial Lipoatrophy (FLA), run by Symatese at 3 sites in France.
Trial summary
Facial lipoatrophy (FLA) refers to the loss of adipose tissue and is manifested by flattening or indentation of convex contours of the face. Most frequently, the subcutaneous layer is affected and most common locations of adipose tissue loss are the cheeks, temples, preauricular, orbital or perioral and oral areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Lipoatrophy (FLA)
- What is being tested?
- Dermal filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Aug 2023to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- If female of child-bearing potential, must have a negative urine pregnancy test before the first injection and use a reliable form of contraception for more than 12 weeks prior to screening and throughout the investigation.
- Note: to be considered females of non-child-bearing potential, females must be surgically sterile or postmenopausal or under highly effective birth control methods as: combined hormonal contraception (containing estrogens and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence documented in medical history for at least 1 year.
- In case of HIV:
- HIV infection with a non-detectable viral charge (viral load <50 copies/mL) confirmed by a recent blood analysis.
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- Patient with platelet count greater than 50,000 cells/L by a recent blood analysis.
- Patient with mild to moderate facial lipoatrophy based on "Ascher lipoatrophy Scale" scale (grade II to IV).
- 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 clinical investigation protocole, 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 who has scars, moles, sunburn, too many hairs, or other blemishes in the test area (face) which would interfere with the evaluation.
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- 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 (other than HIV and related HIV disease).
- 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 (other than HIV and related HIV disease).
- 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 (other than HIV and related HIV disease).
- 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 nonpermanent fillers (e.g., Hyaluronic Acid, CaHA), mesotherapy or neurotoxin near or on the cheeks and/or cheekbones and/or infraorbital hollows 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 cheeks and/or cheekbones and/or infraorbital hollows 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 cheekbones and/or infraorbital hollows.
- Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand etc.).
- Patient having received fat grafting within the past 12 months
- 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 willing to perform any aesthetic treatment on the face other than treatment planned in the protocol during the study period.
- Subject who have planned an intensive exposure to sunlight or UV-rays in the 2 weeks following injection.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Palais de Flore
Lyon, Rhone, 69006
THINKIN
Paris, Île-de-France Region, 75116
Dermatology practice
Saint-Maur-des-Fossés, Île-de-France Region, 94100
About this study
Official title: A Prospective and Multicentric Investigation Evaluating the Clinical Safety of FASY F and FASY P Hyaluronic Acid Gel for the Treatment of Pathological Facial Lipoatrophy
Facial lipoatrophy (FLA) refers to the loss of adipose tissue and is manifested by flattening or indentation of convex contours of the face. Most frequently, the subcutaneous layer is affected and most common locations of adipose tissue loss are the cheeks, temples, preauricular, orbital or perioral and oral areas. Most common etiology for FLA is related to HIV. In 1998, first FLA was described in Subjects under highly active antiretroviral therapy (HAART). Currently, no specific treatment for FLA is known. For HIV-associated FLA, the European AIDS Clinical Society (EACS) recommends in prevention, the avoidance of some ART (Active Antiretroviral therapy) such as stavudine and zidovudine. In corrective purpose, the switch of ART is advisable as well as surgical intervention involving dermal fillers.
Different filling treatment options are available to treat volume defect on FLA Subjects including PolyLactic Acid (PLLA) (i.e.; Sculptra®), Calcium hydroxyapatite ( CaHa - i.e.: Radiesse®), autologous fat graft and hyaluronic acid (HA). Several studies shown promising results for the use of HA in this indication with good reconstructive and aesthetic outcomes, excellent safety profile and comparable to the autologous fat transfer treatment. HA fillers are described as voluming agents for treatment of FLA associated with fat wasting disorders, lasting at least 6 months but the persistent volumetric effect depends on HA crosslinking level and concentration.
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 F and FASY P products for the treatment of FLA.
- Conditions
- Facial Lipoatrophy (FLA)
- Being tested
- Dermal filler
- Keywords
- Hyaluronic acid, Dermal fillers, Lipoatrophy
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal fillerDevice
Subjects will be consecutively included to receive FASY F in nasolabial folds and cheeks and FASY P in periorbital areas.
| Study group | Role | What they receive |
|---|---|---|
| FASY | Experimental | Subjects will be consecutively included to receive FASY F in cheeks and nasolabial folds and FASY P in periorbital areas. Receives: Device: Dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with at least one Injection Site Reaction within 30 days after the last injection.
Recording of the occurrence of local injection site reactions for each injection areas (cheeks, nasolabial folds, periorbital). Assessed by investigators.
Measured: 30 days visit after the last injection.
Secondary outcomes (9)
Injection Site Reactions present within the 14 days of the last injection.
Recording in a daily diary of the presence and severity of local injection site reactions for each injection areas (cheeks, nasolabial folds, periorbital). Assessed by patients.
Measured: During 14 days after the last injection.
Global safety evaluation
Collection of Adverse Event assessed and recorded by investigators.
Measured: Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Visual analogic scale pain assessment.
Description: Assessment of pain using a 0-100mm Visual Analogue Scale for each injection area. (0 corresponds to no pain and 100 corresponds to the highest pain that can be felt).
Measured: Immediately after the injection (for initial injection only)
Lipoatrophy severity modification
Assessemnt of the level of facial lipoatrophy using Ascher Lipoatrophy Scale, a 5-point scale ranking from grade 1: Mild flattening or shadowing of one or more facial regions to grade 5: Severe indentation of one or more facial regions. The lower the score, the better the aesthetic result. Assessed by investigators.
Measured: Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Facial volume quantification
Quantitative measure of cheeks, nasolabial fold and infraorbital hollows volumes (in milliliter) measured using Quantificare® program based on 3D LIFEVIZ mini® photographs.
Measured: Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Quality of life assessement
Assessment of patient's quality of life using the Facial Appearance Inventory scale, a 7-grade scale ranking from 1:very negative to 7: very positive. The higher the score, the better the quality of life. Assessed by patients.
Measured: Day 30, Month 3, Month 6, Month 9 and Month 12 after the last 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: Before touch-up, if any, then at Day 30, Month 3, Month 6, Month 9 and Month 12 after the last 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: Before touch-up, if any, then at Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Implant card readability.
Assessment of the reading and understanding of the FASY F or FASY P implant card by 15 subjects using a questionnaire on which the text present on the implant card must be identified and reported.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start28 Aug 2023
- Primary completion13 Dec 2023
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Lipoatrophy (FLA)Studies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symatese
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776836
- Sponsor's protocol ID
- CLIN2203
- Acronym
- HAtrophy
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 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 and Multicentric Investigation Evaluating the Clinical Safety of FASY F and FASY P Hyaluronic Acid Gel for the Treatment of Pathological Facial Lipoatrophy
- ClinicalTrials.gov ID
- NCT05776836
- Acronym / sponsor ID
- HAtrophy / CLIN2203
- Conditions
- Facial Lipoatrophy (FLA)
- Keywords
- Hyaluronic acid, Dermal fillers, Lipoatrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SymateseIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 20 Mar 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.
Facial lipoatrophy (FLA) refers to the loss of adipose tissue and is manifested by flattening or indentation of convex contours of the face. Most frequently, the subcutaneous layer is affected and most common locations of adipose tissue loss are the cheeks, temples, preauricular, orbital or perioral and oral areas. Most common etiology for FLA is related to HIV. In 1998, first FLA was described in Subjects under highly active antiretroviral therapy (HAART). Currently, no specific treatment for FLA is known. For HIV-associated FLA, the European AIDS Clinical Society (EACS) recommends in prevention, the avoidance of some ART (Active Antiretroviral therapy) such as stavudine and zidovudine. In corrective purpose, the switch of ART is advisable as well as surgical intervention involving dermal fillers.
Different filling treatment options are available to treat volume defect on FLA Subjects including PolyLactic Acid (PLLA) (i.e.; Sculptra®), Calcium hydroxyapatite ( CaHa - i.e.: Radiesse®), autologous fat graft and hyaluronic acid (HA). Several studies shown promising results for the use of HA in this indication with good reconstructive and aesthetic outcomes, excellent safety profile and comparable to the autologous fat transfer treatment. HA fillers are described as voluming agents for treatment of FLA associated with fat wasting disorders, lasting at least 6 months but the persistent volumetric effect depends on HA crosslinking level and concentration.
Detailed description
The study is a pilot, prospective, multicenter, proof-of-concept clinical trial that aims to evaluate the safety and efficacy of FASY F and FASY P products for the treatment of FLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FASY | Experimental | Device: Dermal fillerSubjects will be consecutively included to receive FASY F in cheeks and nasolabial folds and FASY P in periorbital areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sex: male or female.
- Age: 18 years and older.
- If female of child-bearing potential, must have a negative urine pregnancy test before the first injection and use a reliable form of contraception for more than 12 weeks prior to screening and throughout the investigation.
- Note: to be considered females of non-child-bearing potential, females must be surgically sterile or postmenopausal or under highly effective birth control methods as: combined hormonal contraception (containing estrogens and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence documented in medical history for at least 1 year.
- In case of HIV:
Key exclusion criteria (27 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 |
|---|---|---|
| Dermal fillerSubjects will be consecutively included to receive FASY F in nasolabial folds and cheeks and FASY P in periorbital areas. | Device | FASY |
Primary outcome
Proportion of subjects with at least one Injection Site Reaction within 30 days after the last injection.
Time frame: 30 days visit after the last injection.
Recording of the occurrence of local injection site reactions for each injection areas (cheeks, nasolabial folds, periorbital). Assessed by investigators.
9 secondary outcomes
Injection Site Reactions present within the 14 days of the last injection.
Time frame: During 14 days after the last injection.
Global safety evaluation
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Visual analogic scale pain assessment.
Time frame: Immediately after the injection (for initial injection only)
Lipoatrophy severity modification
Time frame: Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Facial volume quantification
Time frame: Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Quality of life assessement
Time frame: Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Patient Global aesthetic improvement
Time frame: Before touch-up, if any, then at Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection..
Investigator Global aesthetic improvement
Time frame: Before touch-up, if any, then at Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.
Implant card readability.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal filler in people with Facial Lipoatrophy (FLA), 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 11 inclusion and 27 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with at least one Injection Site Reaction within 30 days after the last injection. (time frame: 30 days visit after the last 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.