Lipolysis With Sodium Deoxycholate Reduces Submental Fat

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.