Submental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.
J Cosmet Dermatol
; 21(6): 2437-2444, 2022 Jun.
Article
en En
| MEDLINE
| ID: mdl-35278262
ABSTRACT
BACKGROUND:
Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image.AIMS:
To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF.METHODS:
A prospective, open-label, interventional, single-site study enrolling 22- to 65-year-old participants rated as Grade 4 (extreme) on the Clinician-Rated SMF Rating Scale (CR-SMFRS). Co-primary effectiveness endpoints were proportions of participants with ≥1-grade and ≥2-grade improvement on CR-SMFRS at 12 weeks post final treatment. Additional assessments included ultrasound measurement of fat thickness and Subject Self-Rating Scale (SSRS) scores at 12 weeks post final treatment. Safety was assessed throughout the study.RESULTS:
Of 16 enrolled participants, 62.5% were female, mean age of 43, and mean body mass index of 31.8 kg/m2 . 100% of participants achieved ≥1-grade improvement, and 71.4% achieved ≥2-grade CR-SMFRS improvement. Mean (SD) reduction in SMF thickness was 0.2 mm (1.3), and SSRS scores ≥4 (slightly to extremely satisfied) were reported by 71.4% of participants. Adverse events (AEs) were mild and resolved by study end. No unanticipated adverse device effects or serious or unexpected AEs occurred.CONCLUSION:
Sequential treatment with cryolipolysis and ATX-101 was found safe and effective for reducing extreme SMF, resulting in approximately a 2-grade improvement.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Ácido Desoxicólico
/
Grasa Subcutánea
Tipo de estudio:
Observational_studies
Límite:
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
Revista:
J Cosmet Dermatol
Asunto de la revista:
DERMATOLOGIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos