What it means for a patient
- ATX-101 is an injectable drug that destroys fat cells, used here for fat under the chin.
- Treated patients were more often rated improved by clinicians, and more often satisfied with their chin, than those given placebo.
- Caliper measurements confirmed less fat under the chin.
- Loose skin did not get worse.
- Side effects were mostly short-lived and in the treated area. The abstract does not list them by type.
- Treatment took up to four sessions about a month apart.
Why this paper matters
It reported phase III, placebo-controlled results for ATX-101 using clinician ratings, patient ratings and caliper measurements. The authors conclude ATX-101 was effective and well tolerated for nonsurgical reduction of submental fat.
Overview
Fat under the chin (submental fat) is a cosmetic concern, and at the time the ways to reduce it were either invasive or lacked evidence. This double-blind, placebo-controlled, multicenter phase III study gave 363 patients with moderate or severe submental fat ATX-101 at 1 or 2 mg/cm² or placebo. Patients had up to four treatment sessions about 28 days apart, with 12 weeks of follow-up.
Findings
- 363 patients were randomized to ATX-101 1 mg/cm², ATX-101 2 mg/cm² or placebo.
- Co-primary endpoint 1, clinician scale (at least 1-point improvement on the 5-point CR-SMFRS): 59.2% (1 mg) and 65.3% (2 mg) vs 23.0% with placebo (P < 0.001).
- Co-primary endpoint 2, patient scale (satisfied with face and chin on the SSRS): 53.3% and 66.1% vs 28.7% with placebo (P < 0.001).
- Caliper measurements showed a significant reduction in submental fat (P < 0.001).
- Skin laxity was not worsened.
- Patients reported improvement in the severity and psychological impact of submental fat vs placebo.
- Most adverse events were transient and associated with the treatment area.
Terms
- Submental fat (SMF): fat under the chin.
- ATX-101 (deoxycholic acid): an injectable form of a bile acid that destroys fat cells.
- Adipocytolytic: destroys fat cells.
- Phase III trial: a large trial that tests whether a drug works and is safe before approval.
- Placebo: an inactive injection used for comparison.
- Double-blind: neither patients nor investigators know who received the drug.
- Co-primary endpoints: the two main outcomes a trial is designed to meet.
- CR-SMFRS: the Clinician-Reported Submental Fat Rating Scale.
- SSRS: the Subject Self-Rating Scale, a patient rating of satisfaction with appearance.
- Caliper: an instrument that measures the thickness of a fold of skin and fat.
- Skin laxity: looseness of the skin.