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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will be consecutively included to receive FASY F in nasolabial folds and cheeks and FASY P in periorbital areas.
Palais de Flore
Lyon, Rhone, France
THINKIN
Paris, Île-de-France Region, France
Dermatology practice
Saint-Maur-des-Fossés, Île-de-France Region, France
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
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