What it means for a patient
- ATX-101 is an injectable drug that reduces fat under the chin without surgery.
- More treated patients than placebo patients improved on the clinician scale and were satisfied with their chin.
- Treatment was given up to four times, about a month apart.
- Loose skin did not get worse overall.
- Side effects were mostly mild to moderate, short-lived and in the treated area.
- The authors state it may be an alternative to surgery. This trial compared it with placebo and did not include a surgery group.
Why this paper matters
It reported phase III, placebo-controlled results for ATX-101 with both clinician-rated and patient-reported measures. It included measures of emotional impact and self-image.
Overview
Unwanted fat under the chin (submental fat) can affect the chin profile and satisfaction with appearance. At the time, no approved and rigorously tested nonsurgical treatment existed. This randomized, double-blind, placebo-controlled phase III study gave 360 patients with moderate or severe submental fat ATX-101 at 1 or 2 mg/cm² or placebo. Patients had up to four treatments about 28 days apart, with 12 weeks of follow-up.
Findings
- 360 patients were randomized to ATX-101 1 mg/cm², ATX-101 2 mg/cm² or placebo.
- Clinician-rated improvement of at least 1 point (CR-SMFRS): 58.3% (1 mg) and 62.3% (2 mg) vs 34.5% with placebo (P < 0.001).
- Satisfied with the appearance of the face and chin (SSRS score 4 or higher): 68.3% and 64.8% vs 29.3% with placebo (P < 0.001).
- Patient-rated fat severity (PR-SMFRS) improved: P = 0.009 for 1 mg and P < 0.001 for 2 mg vs placebo.
- Emotional impact and perceived self-image (PR-SMFIS) improved (P < 0.001).
- No overall worsening of skin laxity was seen.
- Adverse events were mostly transient, mild to moderate and localized to the treated area.
Terms
- Submental fat (SMF): fat under the chin.
- ATX-101 (deoxycholic acid): an injectable form of a bile acid that 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.
- CR-SMFRS: the Clinician-Reported Submental Fat Rating Scale.
- SSRS: the Subject Self-Rating Scale, a patient rating of satisfaction with appearance.
- PR-SMFIS: the Patient-Reported Submental Fat Impact Scale, which measures emotional and visual impact.
- Skin laxity: looseness of the skin.