Beer and colleagues1 presented a poster at The 2016 Fall Clinical Dermatology Conference, in Las Vegas, NV, on a trial conducted at 21 sites in the US that evaluated the safety and efficacy of ATX-101 (deoxycholic acid injection, Kybella) in subjects followed for up to 12 months after last treatment.
Adults (18–65 years) with with moderate to extreme submental fat (as assessed via the validated Clinician-Reported and Patient- Reported SMF Rating Scales [CR-SMFRS and PR-SMFRS, respectively]) who were dissatisfied with the appearance of their face/chin were enrolled in the study. Subjects received up to 6 treatment sessions (every 28 ± 5 days) of ATX-101 (2 mg/cm2) administered by subcutaneous injection into submental fat. Efficacy was evaluated using clinician and subject-reported outcomes throughout the treatment period and at 4 weeks, 12 weeks, and 12 months after last treatment. Safety was monitored throughout the trial via spontaneous adverse event (AE) reports and evaluation of skin laxity. In addition, the researchers looked at the impact of ATX-101 treatment on work and social/leisure activities using patient questionnaire at each visit.
Results from the multicenter, open-label phase 3b trial demonstrated that ATX-101 treatment reduced submental fat and the psychological impact of submental fat without worsening skin laxity, researchers concluded. Initial reductions in submental fat and high levels of subject satisfaction were maintained over 12 months of follow-up. The researchers found that most AEs were related to the injection site and mild/moderate. For most participants, downtime was minimal and occurred most commonly after the initial treatment session with ATX-101.
Reference
1. Beer KR, Weinkle SH, Cox SE, et al. Safety and Efficacy of ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat:Results From a Multicenter, Open-label Phase 3b Trial. Poster presented at The 2016 35th Anniversary Fall Clinical Dermatology Conference, Las Vegas, Nevada. October 20-23, 2016.
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Phase 3b Confirms Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Submental Fat
Beer and colleagues1 presented a poster at The 2016 Fall Clinical Dermatology Conference, in Las Vegas, NV, on a trial conducted at 21 sites in the US that evaluated the safety and efficacy of ATX-101 (deoxycholic acid injection, Kybella) in subjects followed for up to 12 months after last treatment.
Adults (18–65 years) with with moderate to extreme submental fat (as assessed via the validated Clinician-Reported and Patient- Reported SMF Rating Scales [CR-SMFRS and PR-SMFRS, respectively]) who were dissatisfied with the appearance of their face/chin were enrolled in the study. Subjects received up to 6 treatment sessions (every 28 ± 5 days) of ATX-101 (2 mg/cm2) administered by subcutaneous injection into submental fat. Efficacy was evaluated using clinician and subject-reported outcomes throughout the treatment period and at 4 weeks, 12 weeks, and 12 months after last treatment. Safety was monitored throughout the trial via spontaneous adverse event (AE) reports and evaluation of skin laxity. In addition, the researchers looked at the impact of ATX-101 treatment on work and social/leisure activities using patient questionnaire at each visit.
Results from the multicenter, open-label phase 3b trial demonstrated that ATX-101 treatment reduced submental fat and the psychological impact of submental fat without worsening skin laxity, researchers concluded. Initial reductions in submental fat and high levels of subject satisfaction were maintained over 12 months of follow-up. The researchers found that most AEs were related to the injection site and mild/moderate. For most participants, downtime was minimal and occurred most commonly after the initial treatment session with ATX-101.
Reference
1. Beer KR, Weinkle SH, Cox SE, et al. Safety and Efficacy of ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat:Results From a Multicenter, Open-label Phase 3b Trial. Poster presented at The 2016 35th Anniversary Fall Clinical Dermatology Conference, Las Vegas, Nevada. October 20-23, 2016.
Beer and colleagues1 presented a poster at The 2016 Fall Clinical Dermatology Conference, in Las Vegas, NV, on a trial conducted at 21 sites in the US that evaluated the safety and efficacy of ATX-101 (deoxycholic acid injection, Kybella) in subjects followed for up to 12 months after last treatment.
Adults (18–65 years) with with moderate to extreme submental fat (as assessed via the validated Clinician-Reported and Patient- Reported SMF Rating Scales [CR-SMFRS and PR-SMFRS, respectively]) who were dissatisfied with the appearance of their face/chin were enrolled in the study. Subjects received up to 6 treatment sessions (every 28 ± 5 days) of ATX-101 (2 mg/cm2) administered by subcutaneous injection into submental fat. Efficacy was evaluated using clinician and subject-reported outcomes throughout the treatment period and at 4 weeks, 12 weeks, and 12 months after last treatment. Safety was monitored throughout the trial via spontaneous adverse event (AE) reports and evaluation of skin laxity. In addition, the researchers looked at the impact of ATX-101 treatment on work and social/leisure activities using patient questionnaire at each visit.
Results from the multicenter, open-label phase 3b trial demonstrated that ATX-101 treatment reduced submental fat and the psychological impact of submental fat without worsening skin laxity, researchers concluded. Initial reductions in submental fat and high levels of subject satisfaction were maintained over 12 months of follow-up. The researchers found that most AEs were related to the injection site and mild/moderate. For most participants, downtime was minimal and occurred most commonly after the initial treatment session with ATX-101.
Reference
1. Beer KR, Weinkle SH, Cox SE, et al. Safety and Efficacy of ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat:Results From a Multicenter, Open-label Phase 3b Trial. Poster presented at The 2016 35th Anniversary Fall Clinical Dermatology Conference, Las Vegas, Nevada. October 20-23, 2016.
