Evaluation of HA Dermal Fillers in the Treatment of Pathological Facial Lipoatrophy

NCT05776836 | Completed DMC

• 1 other identifier: CLIN2203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Facial Lipoatrophy (FLA)

Keywords

Hyaluronic acid; Dermal fillers; Lipoatrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days visit after the last injection.

Secondary Outcomes (9)

• Injection Site Reactions present within the 14 days of the last injection.

  During 14 days after the last injection.

• Global safety evaluation

  Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.

• Visual analogic scale pain assessment.

  Immediately after the injection (for initial injection only)

• Lipoatrophy severity modification

  Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.

• Facial volume quantification

  Baseline, Day 30, Month 3, Month 6, Month 9 and Month 12 after the last injection.

Study Arms (1)

FASY

EXPERIMENTAL

Subjects will be consecutively included to receive FASY F in cheeks and nasolabial folds and FASY P in periorbital areas.

Device: Dermal filler

Interventions

Dermal filler DEVICE

Subjects will be consecutively included to receive FASY F in nasolabial folds and cheeks and FASY P in periorbital areas.

FASY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 who has scars, moles, sunburn, too many hairs, or other blemishes in the test area (face) which would interfere with the evaluation.
• 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.

Sponsors & Collaborators

• Symatese: lead
• EVAMED: collaborator

Study Sites (3)

Palais de Flore

Lyon, Rhone, 69006, France

Location

THINKIN

Paris, Île-de-France Region, 75116, France

Location

Dermatology practice

Saint-Maur-des-Fossés, Île-de-France Region, 94100, France

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 20, 2023
• Study Start: August 28, 2023
• Primary Completion: December 13, 2023
• Study Completion: November 26, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)