Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.
Aesthet Surg J
; 41(11): NP1532-NP1539, 2021 10 15.
Article
en En
| MEDLINE
| ID: mdl-33617632
ABSTRACT
BACKGROUND:
ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).OBJECTIVES:
The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101.METHODS:
REFINE study patients who maintained ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after their last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). The primary endpoint was CR-1 response at Years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored.RESULTS:
In total, 224 patients (ATX-101, nâ =â 113; placebo, nâ =â 111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group than in the placebo group at Year 1 (86.4% vs 56.8%; Pâ <â 0.001), Year 2 (90.6% vs 73.8%; Pâ =â 0.014), and Year 3 (82.4% vs 65.0%; Pâ =â 0.03). Most (74%) ATX-101âtreated patients satisfied at 12 weeks remained satisfied at Year 3. Significant reductions from baseline in psychological impact scores were sustained through Year 3 (Pâ <â 0.001). No new treatment-related adverse events were reported.CONCLUSIONS:
Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Técnicas Cosméticas
/
Ácido Desoxicólico
Tipo de estudio:
Clinical_trials
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Observational_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Aesthet Surg J
Año:
2021
Tipo del documento:
Article
País de afiliación:
Canadá