An interventional study of Dermal filler in Facial Lipoatrophy (FLA), sponsored by Symatese. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Symatese · Not applicable, Interventional, and Treatment
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.
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.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 97 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Symatese is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If female of , must have a negative urine pregnancy test before the first injection and use a reliable form of 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 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 :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be consecutively included to receive FASY F in cheeks and nasolabial folds and FASY P in periorbital areas.
Device: Dermal filler
Subjects will be consecutively included to receive FASY F in nasolabial folds and cheeks and FASY P in periorbital areas.
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.
Time frame: 30 days visit after the last injection.
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.
Time frame: During 14 days after the last injection.
Global safety evaluation
Collection of Adverse Event assessed and recorded by investigators.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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.
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.
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Dec 2023, 3 months.
Of 23 interventional studies with no phase under Lipodystrophy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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