Background: Submental fat (SMF) can contribute to an unwanted fullness under the chin, negatively impacting appearance and psychological well-being. Many treatments are available for submental contouring, including liposuction, injectable treatment, and energy-based devices. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide a better understanding of the condition of submental fullness and its treatment in clinical practice.
Methods: CONTOUR (NCT02438813) is a prospective, observational registry enrolling adults considering treatment to reduce their SMF. Patients are followed until treatment is completed, discontinued, or 1 year elapsed from enrollment without treatment. Interim data are reported in this abstract.
Results: As of July 27, 2016, 1030 patients have been enrolled across 91 sites (71% dermatology; 28% plastic surgery; 1% ophthalmology sites). Overall, 617/1030 (59.9%) patients have received ≥1 treatment for their SMF (ATX-101 [deoxycholic acid injection; n=533], energy-based devices [n=67], surgical liposuction [n=13], laser liposuction [n=4], other treatments [n=7]), while 413/1030 (40.1%) have not chosen to undergo treatment for their SMF. Of the 413 patients who have not opted for treatment, 137 patients noted a primary reason. The most common reason cited for not undergoing treatment for their SMF was that treatment options are too expensive (noted by 50/137 patients). At enrollment, mean age across all patients treated for their SMF was 50.1 years and ranged from a mean of 49.3 years (surgical liposuction group) to 54.7 years (other treatments group). Overall, most patients treated for their SMF were female (mean: 83.9%; mean range across treatment groups: 75.0%–92.4%), white (84.6%; 57.1%–100%), and not Hispanic/Latino (94.2%; 92.3%–100%). Based on clinician assessment via the validated Clinician-Reported SMF Rating Scale, there was a markedly greater percentage of patients with severe SMF at enrollment in the surgical liposuction and laser liposuction groups (61.5% and 50.0%, respectively) compared with the other treatments group (28.6%), ATX-101 group (19.7%), and energy-based devices group (15.2%). At enrollment, 48.4% of all patients treated for their SMF had mild skin laxity as assessed by the clinician. There was a relatively even distribution of patients with moderate skin laxity at enrollment across the energy-based devices group (28.8%), other treatments group (28.6%), and ATX-101 group (22.5%). However, there was a much greater percentage of patients with moderate skin laxity in the surgical liposuction group (46.2%). Across all treatment groups, patients reported substantial psychological impact from SMF at enrollment based on the validated Patient-Reported SMF Impact Scale (mean: 6.9/10 [greatest negative impact]). Patients who selected either laser liposuction or surgical liposuction tended to report greater psychological impact from their SMF (mean: 9.0 and 8.2, respectively) versus patients who selected either ATX-101 treatment (6.8) or energy-based devices (6.4). Several treatment options in CONTOUR may require only a single treatment session, such as surgical liposuction and laser liposuction, while other treatment options may require multiple treatment sessions, such as ATX-101 and energy-based devices. As of July 27, 2016, all 533 patients who selected ATX-101 treatment have received ≥1 treatment session, 286 have received ≥2 treatment sessions, 60 have received ≥3 treatment sessions, and 8 have received ≥4 treatment sessions (up to 6 treatment sessions permitted). The overall incidence of adverse events (AEs) was 10.9% across all treatment groups and ranged from 7.7% (surgical liposuction group) to 28.6% (other treatments group). All AEs were mild or moderate. No serious AEs were reported.
Conclusion: Data from CONTOUR provide information regarding the real-world treatment of undesirable submental fullness and provide a better understanding of patient and clinician perspectives about the various viable treatment options for improving submental contour.