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NCT05776836: HAtrophy
Evaluation of HA Dermal Fillers in the Treatment of Pathological Facial Lipoatrophy
NA trial testing Dermal filler in Facial Lipoatrophy (FLA) in 30 participants. Completed in 26 November 2024.
13 December 2023
Quick facts
| Lead sponsor | Symatese |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 28 August 2023 |
| Primary completion | 13 December 2023 |
| Estimated completion | 26 November 2024 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Dermal filler
Conditions studied
- Facial Lipoatrophy (FLA) — all drugs for Facial Lipoatrophy (FLA) →
Sponsor
Symatese
Who can join
18 and older, any sex, with Facial Lipoatrophy (FLA). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05776836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Symatese trials
Trials by the same sponsor.
- NCT06097988 — Study on Knee Osteoarthritis · NA · completed
- NCT05825170 — Evaluation of a HA Dermal Filler in the Treatment of Lip Deformity · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05776836 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Symatese
- Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05776836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing