Evaluation of HA Dermal Fillers in the Treatment of Pathological Facial Lipoatrophy (NCT05776836) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of HA Dermal Fillers in the Treatment of Pathological Facial Lipoatrophy
France30 participantsStarted 2023-08-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. In case of HIV:
✓. 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.
Exclusion criteria
✕. Pregnant and breastfeeding women
✕
What they're measuring
1
Proportion of subjects with at least one Injection Site Reaction within 30 days after the last injection.
Timeframe: 30 days visit after the last injection.
. 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.
✕. 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.