番茄社区

SAN FRANCISCO -- Double chins melted away from patients with a wide range of clinical, social, and demographic characteristics following injection with a synthetic deoxycholic acid compound, investigators reported here.

Subcutaneously administered ATX-101 achieved consistent reductions in submental fat accumulation, regardless of patient age, ethnicity, sex, body mass index (BMI), or skin condition. The findings extend the previously reported overall results, which showed almost a 70% response rate by clinician and patient assessment.

"ATX-101 significantly reduced submental fat compared with placebo based on both clinician-reported and subject-reported outcome measures in all subgroups evaluated," , of Dermatology Research Institute in Coral Gables, Fla., and colleagues reported in a poster presentation at the American Academy of Dermatology meeting. "Among ATX-101 treated subgroups of the same demographic, consistent clinician-rated responses were noted."

Adverse events were generally transient, mild or moderate in severity, and rarely led to discontinuation, they added.

Earlier this month, an FDA advisory committee as a treatment for submental fat accumulation. Although the FDA is not bound by a committee recommendation, the agency usually follows committee guidance, which in this case, could pave the way for approval of the nonsurgical approach to treating double chin.

Double chin, or excess submental fat accumulation, affects a majority of people at one time or another. Some studies have found as many as 90% of adults think they have double chins and that their appearance might be improved by removing the excess fat.

The most common approaches to treating submental fat accumulation involve surgery, including face lift and liposuction. In contrast, ATX-101 consists of a deoxycholic acid formulation manufactured without the use of animal products. Upon injection into the target area, the , leading to irreversible cell lysis and septal thickening and possibly new collagenesis.

ATX-101 was evaluated in two pivotal, randomized, placebo-controlled trials conducted in the U.S. and Canada. Investigators enrolled adults who had moderate or severe submental fat accumulation (grade 2 or 3 by the Clinician-Reported Submental Fat Rating Scale). The patients received as many as six subcutaneous injections administered 28 days apart.

Patients in both trials were evaluated by validated clinician and patient assessment scales. The trials had co-primary endpoints: the proportion of patients with at least one grade improvement in the composite of the clinician and patient scales and the proportion of patients who had at least a two-grade improvement in the composite assessment.

The two trials combined involved 1,022 patients, who had a mean age of 49, and 85% of the study participants were women. By clinician assessment, the patients were evenly divided between grade 2 and 3 submental fat accumulation. Patient assessment placed the distribution at 63% grade 2 and 37% grade 3.

In the two trials combined, clinicians and patients agreed that a one-grade improvement in submental fat accumulation occurred in 68.2% of cases, as compared with 20.5% of patients randomized to placebo (P<0.001). Clinicians and patients also agreed that ATX-101 reduced submental fat accumulation significantly more often than did placebo (P<0.001), although Brandt did not report the data.

Brandt and colleagues analyzed the data for consistency of the effect of ATX-101 across different patient subgroups with respect to the composite clinician/patient assessment of at least one-grade improvement in submental fat accumulation. The analysis showed a consistent effect across all the subgroups with respect to clinician rate, patient rating, and the combined rating.

For example, clinicians and patients agreed on at least a one-grade improvement in about 80% of cases overall, a similar proportion for women only, and more than 70% of the men treated with ATX-101. The difference from placebo averaged 40% to 50% across the different analyses.

Similar consistency was observed with respect to age (<50, 50-plus, and 10-year increments), race/ethnicity, BMI, skin type and laxity, and baseline submental fat accumulation.

Photos of individual patients showed reductions in submental fat accumulation even in patients who gained weight during the trial or had a higher BMI at the end than at the beginning.

Analysis of adverse events showed that hematoma occurred in a similar proportion of patients in the ATX-101 and placebo groups (about 70%).

Other adverse events occurred more often with ATX-101 but generally were transient and not severe, including pain (69.5% versus 31.3%), numbness (66.2% versus 5.8%), edema (60.4% versus 29.2%), swelling (33.2% versus 15.7%), erythema (26.6%, versus 17.9%), induration (23.3% versus 2.6%), and smaller percentages for paresthesia, nodule, and pruritus.

A related poster presentation showed that the reduction in submental fat accumulation correlated with favorable changes in patient-reported outcomes, including a subjective self-rating scale and global questions related to satisfaction and well-being.

A good candidate for treatment with ATX-101 has substantial submental fullness, relatively firm skin (limited laxity), and a particular interest in treating just the submental area, Brandt told 番茄社区. Before deciding to proceed with the treatment, patients should know that they might need to recuperate for several days after a procedure, allowing swelling and bruising in the neck to subside.

Whether ATX-101 has potential for reducing fat accumulation in other areas of the body has not been evaluated, he added.

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