Results from a Pooled Analysis of Two European, Randomized, Placebo-Controlled, Phase 3 Studies of ATX-101 for the Pharmacologic Reduction of Excess Submental Fat
| Autor: | James McDiarmid, Claudia Hartisch, Daniel Lee, Susanne Lippert, Blanka Havlickova, Jesus Benito Ruiz |
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| Jazyk: | angličtina |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Intradermal Post hoc Subcutaneous Fat Urology Deoxycholic acid Nonsurgical Cell-Penetrating Peptides Cosmetic Techniques ATX-101 Placebo Body Mass Index medicine Humans Multicenter Studies as Topic Randomized Controlled Trials as Topic Adipocytolysis business.industry Submental fat Nonsurgical treatment Surgery Clinical trial Injectable Pooled analysis Clinical Trials Phase III as Topic Patient Satisfaction Meta-analysis Female Original Article Anti-Obesity Agents business Clinical evaluation Body mass index |
| Zdroj: | Aesthetic Plastic Surgery |
| ISSN: | 0364-216X |
| DOI: | 10.1007/s00266-014-0364-9 |
| Popis: | Background The injectable adipocytolytic drug ATX-101 is the first nonsurgical treatment for the reduction of submental fat (SMF) to undergo comprehensive clinical evaluation. This study aimed to confirm the efficacy and safety of ATX-101 for SMF reduction through a post hoc pooled analysis of two large phase 3 studies. Methods Patients with unwanted SMF were randomized to receive 1 or 2 mg/cm2 of ATX-101 or a placebo injected into their SMF during a maximum of four treatment sessions spaced approximately 28 days apart, with a 12-week follow-up period. The proportions of patients with reductions in SMF of one point or more on the Clinician-Reported SMF Rating Scale (CR-SMFRS) and the proportions of patients satisfied with the appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4] were reported overall and in subgroups. Other efficacy measures included improvements in the Patient-Reported SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS)]. Adverse events and laboratory test results were recorded. Results Significantly greater proportions of the patients had improvements in clinician-reported measures (≥1-point improvement in CR-SMFRS: 58.8 and 63.8 % of the patients who received ATX-101 1 and 2 mg/cm2, respectively, and 28.6 % of the placebo recipients; p |
| Databáze: | OpenAIRE |
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