A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat.
Dermatol Surg
; 45(12): 1531-1541, 2019 12.
Article
em En
| MEDLINE
| ID: mdl-30998531
ABSTRACT
BACKGROUND:
ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF).OBJECTIVE:
To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF. PATIENTS ANDMETHODS:
Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events.RESULTS:
Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site.CONCLUSION:
ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ritidoplastia
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Satisfação do Paciente
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Ácido Desoxicólico
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Gordura Subcutânea
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article