Deoxycholic acid effective in trimming extreme and very mild chin fat

CHICAGO – Deoxycholic acid injections benefit patients on either end of the spectrum with mild or extreme submental fat, a phase III safety study shows.

“What this study shows is that the applicability of the product is wider than what’s represented in the registration trials because they looked at a very narrow band and this includes people with very mild and extreme [submental fat],” Dr. Richard G. Glogau of San Francisco Dermatology and the University of California, San Francisco, said in an interview. He presented the results of the study at the annual meeting of the American Society for Dermatologic Surgery.

Deoxycholic acid gained U.S. approval in April 2015 as the first injectable cytolytic drug to treat moderate to severe convexity or fullness associated with submental fat (SMF) in adults. It is marketed as Kybella.

Because treatment can be tailored based on the amount and thickness of SMF, the study sought to evaluate deoxycholic acid 2 mg/cm² or placebo for up to six treatments 1 month apart in 47 patients with mild SMF and 46 patients with extreme SMF based on Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) scores of 1 (mild) or 4 (extreme).

The predominantly female cohort had an average age of 48 years in the mild SMF group and 51 years in the extreme SMF group and a mean body mass index of 25 kg/m² and 32.5 kg/m², respectively. About 30% of patients in the extreme SMF group had moderate to severe skin laxity compared with about 15% in the mild SMF group.

The mean number of treatment sessions was 4.9 for placebo and 4.2 for deoxycholic acid in the mild SMF group, and 5.6 for placebo and 4.9 for deoxycholic acid in the extreme SMF group.

“I don’t think in the real world that’s our experience,” Dr. Glogau said at the meeting. “People in the mild group get by with much less and, conversely, people at the extreme end would be happy to go on higher than four or five treatments, depending on what size they started with.”

The mean total injection volume across all treatments was 17.2 mL, 13.9 mL, 38.4 mL, and 31.6 mL, respectively, which is consistent with the need for less product in mild SMF.

In the mild SMF group, SMF was reduced by one grade in significantly more patients following deoxycholic acid treatment than placebo as measured with the CR-SMFRS (74.2% vs. 20%), the Patient-Rated SMFRS (67.7% vs. 33.3%), or a composite of the two scales (61.3% vs. 6.7%).

The percentages of patients with extreme SMF achieving a one-grade improvement with deoxycholic acid were even higher: CR-SMFRS (96.4% vs. 26.7%), PR-SMFRS (89.3% vs. 46.7%), or the composite (89.3% vs. 13.3%), said Dr. Glogau.

Moreover, SMF improved by two grades on the composite endpoint in 43% of extreme SMF patients treated with deoxycholic acid vs. 0% given placebo. P values for all comparisons were less than .05.

“To reach a two-grade change in virtually anything you want to study is difficult to achieve, so I think this is a significant landmark that came out of this study,” Dr. Glogau said.

Significantly more deoxycholic acid–treated patients also reported being satisfied with the appearance of their face and chin compared with those given placebo in the mild SMF (80% vs. 46.7%; P less than .05) and extreme SMF (71.4% vs. 0%; P less than .05) groups.

Despite reductions in SMF, skin laxity was unchanged or got only slightly better from baseline in all patients on deoxycholic acid. This is not surprising, because deoxycholic acid exerts its killing effect on fat cells only, not on fibrous septae or the dermis, and skin laxity is a reflection of inherent elasticity in the dermis, together with the fibrous septae in the fat running between skin and muscle, Dr. Glogau explained.

Most adverse events were mild or moderate in severity and transient in nature, he said. Among mild SMF patients, pain was reported in 74% treated with deoxycholic acid vs. 50% with placebo, bruising in 48% vs. 50%, edema in 42% vs. 25%, numbness in 48% vs. 6%, and swelling in 42% vs. 13%. The percentages were generally similar in the extreme SMF group.

“I think the incidence of hematoma and bruising is actually a function of injection technique and numbers out in clinical practice are somewhat lower,” Dr. Glogau observed.

No drug-related serious adverse events were reported. Nerve paresis was reported in two deoxycholic acid–treated patients with mild SMF and resolved without sequelae after 4 days and after 52 days.

Dysphagia was reported in one deoxycholic acid–treated patient with extreme SMF and resolved without sequelae after 2 days.

None of the events precluded patients from receiving additional treatment, even within the 30-day interval, he said, adding that in practice most clinicians are using longer breaks between treatments.

During a discussion of the study, Dr. Glogau said he uses lidocaine to reduce pain and that local anesthesia should be standard with deoxycholic acid injections.

Fellow presenter Dr. Brian Biesman, director of the Nashville (Tenn.) Centre for Laser and Facial Surgery, said that he was injected with deoxycholic acid both with and without local anesthesia and that they’ve used local anesthesia ever since.

“It makes a huge difference from a patient experience standpoint, of being extraordinarily unpleasant without it – and I have a pretty good pain tolerance – to being extraordinarily unremarkable,” Dr. Biesman said.

Session moderator Dr. Wendy Roberts of Dermatology Rancho Mirage (Calif.), said that Dr. Glogau’s study provides clinicians with data to support deoxycholic acid use in a broader range of patients.

“Now we have a real resource that we can reference and say as a matter of fact, for mild submental fullness you will get a result and this is the study. So you’re not wasting your money, you’re not wasting your time,” she said in an interview. “I think it’s extremely important. In Southern California where I practice, people don’t want to get to be moderate to severe.”

The oral abstract session included several other deoxycholic acid presentations including long-term follow-up from phase II/III trials showing that improvements in SMF severity are maintained for up to 4 years after treatment. The improvements were due to deoxycholic acid treatment, as body weight did not significantly change throughout the follow-up period, said study author Dr. Ashish Bhatia of the DuPage Medical Group, in Naperville, Ill.

Dr. Kenneth Beer of Palm Beach (Fla.) Cosmetic, provided details on the ongoing Kythera-sponsored CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry study looking at how SMF is treated in clinical practice and the risks and benefits associated with treatment.

Kythera Biopharmaceuticals markets Kybella, which is also known as ATX-101. Dr. Glogau, Dr. Roberts, Dr. Bhatia, and Dr. Beer reported ties to Kythera. Several coauthors also disclosed ties to the company.

pwendling@frontlinemedcom.com

CHICAGO – Deoxycholic acid injections benefit patients on either end of the spectrum with mild or extreme submental fat, a phase III safety study shows.

“What this study shows is that the applicability of the product is wider than what’s represented in the registration trials because they looked at a very narrow band and this includes people with very mild and extreme [submental fat],” Dr. Richard G. Glogau of San Francisco Dermatology and the University of California, San Francisco, said in an interview. He presented the results of the study at the annual meeting of the American Society for Dermatologic Surgery.

Deoxycholic acid gained U.S. approval in April 2015 as the first injectable cytolytic drug to treat moderate to severe convexity or fullness associated with submental fat (SMF) in adults. It is marketed as Kybella.

Because treatment can be tailored based on the amount and thickness of SMF, the study sought to evaluate deoxycholic acid 2 mg/cm² or placebo for up to six treatments 1 month apart in 47 patients with mild SMF and 46 patients with extreme SMF based on Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) scores of 1 (mild) or 4 (extreme).

The predominantly female cohort had an average age of 48 years in the mild SMF group and 51 years in the extreme SMF group and a mean body mass index of 25 kg/m² and 32.5 kg/m², respectively. About 30% of patients in the extreme SMF group had moderate to severe skin laxity compared with about 15% in the mild SMF group.

The mean number of treatment sessions was 4.9 for placebo and 4.2 for deoxycholic acid in the mild SMF group, and 5.6 for placebo and 4.9 for deoxycholic acid in the extreme SMF group.

“I don’t think in the real world that’s our experience,” Dr. Glogau said at the meeting. “People in the mild group get by with much less and, conversely, people at the extreme end would be happy to go on higher than four or five treatments, depending on what size they started with.”

The mean total injection volume across all treatments was 17.2 mL, 13.9 mL, 38.4 mL, and 31.6 mL, respectively, which is consistent with the need for less product in mild SMF.

In the mild SMF group, SMF was reduced by one grade in significantly more patients following deoxycholic acid treatment than placebo as measured with the CR-SMFRS (74.2% vs. 20%), the Patient-Rated SMFRS (67.7% vs. 33.3%), or a composite of the two scales (61.3% vs. 6.7%).

The percentages of patients with extreme SMF achieving a one-grade improvement with deoxycholic acid were even higher: CR-SMFRS (96.4% vs. 26.7%), PR-SMFRS (89.3% vs. 46.7%), or the composite (89.3% vs. 13.3%), said Dr. Glogau.

Moreover, SMF improved by two grades on the composite endpoint in 43% of extreme SMF patients treated with deoxycholic acid vs. 0% given placebo. P values for all comparisons were less than .05.

“To reach a two-grade change in virtually anything you want to study is difficult to achieve, so I think this is a significant landmark that came out of this study,” Dr. Glogau said.

Significantly more deoxycholic acid–treated patients also reported being satisfied with the appearance of their face and chin compared with those given placebo in the mild SMF (80% vs. 46.7%; P less than .05) and extreme SMF (71.4% vs. 0%; P less than .05) groups.

Despite reductions in SMF, skin laxity was unchanged or got only slightly better from baseline in all patients on deoxycholic acid. This is not surprising, because deoxycholic acid exerts its killing effect on fat cells only, not on fibrous septae or the dermis, and skin laxity is a reflection of inherent elasticity in the dermis, together with the fibrous septae in the fat running between skin and muscle, Dr. Glogau explained.

Most adverse events were mild or moderate in severity and transient in nature, he said. Among mild SMF patients, pain was reported in 74% treated with deoxycholic acid vs. 50% with placebo, bruising in 48% vs. 50%, edema in 42% vs. 25%, numbness in 48% vs. 6%, and swelling in 42% vs. 13%. The percentages were generally similar in the extreme SMF group.

“I think the incidence of hematoma and bruising is actually a function of injection technique and numbers out in clinical practice are somewhat lower,” Dr. Glogau observed.

No drug-related serious adverse events were reported. Nerve paresis was reported in two deoxycholic acid–treated patients with mild SMF and resolved without sequelae after 4 days and after 52 days.

Dysphagia was reported in one deoxycholic acid–treated patient with extreme SMF and resolved without sequelae after 2 days.

None of the events precluded patients from receiving additional treatment, even within the 30-day interval, he said, adding that in practice most clinicians are using longer breaks between treatments.

During a discussion of the study, Dr. Glogau said he uses lidocaine to reduce pain and that local anesthesia should be standard with deoxycholic acid injections.

Fellow presenter Dr. Brian Biesman, director of the Nashville (Tenn.) Centre for Laser and Facial Surgery, said that he was injected with deoxycholic acid both with and without local anesthesia and that they’ve used local anesthesia ever since.

“It makes a huge difference from a patient experience standpoint, of being extraordinarily unpleasant without it – and I have a pretty good pain tolerance – to being extraordinarily unremarkable,” Dr. Biesman said.

Session moderator Dr. Wendy Roberts of Dermatology Rancho Mirage (Calif.), said that Dr. Glogau’s study provides clinicians with data to support deoxycholic acid use in a broader range of patients.

“Now we have a real resource that we can reference and say as a matter of fact, for mild submental fullness you will get a result and this is the study. So you’re not wasting your money, you’re not wasting your time,” she said in an interview. “I think it’s extremely important. In Southern California where I practice, people don’t want to get to be moderate to severe.”

The oral abstract session included several other deoxycholic acid presentations including long-term follow-up from phase II/III trials showing that improvements in SMF severity are maintained for up to 4 years after treatment. The improvements were due to deoxycholic acid treatment, as body weight did not significantly change throughout the follow-up period, said study author Dr. Ashish Bhatia of the DuPage Medical Group, in Naperville, Ill.

Dr. Kenneth Beer of Palm Beach (Fla.) Cosmetic, provided details on the ongoing Kythera-sponsored CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry study looking at how SMF is treated in clinical practice and the risks and benefits associated with treatment.

Kythera Biopharmaceuticals markets Kybella, which is also known as ATX-101. Dr. Glogau, Dr. Roberts, Dr. Bhatia, and Dr. Beer reported ties to Kythera. Several coauthors also disclosed ties to the company.

pwendling@frontlinemedcom.com

CHICAGO – Deoxycholic acid injections benefit patients on either end of the spectrum with mild or extreme submental fat, a phase III safety study shows.

“What this study shows is that the applicability of the product is wider than what’s represented in the registration trials because they looked at a very narrow band and this includes people with very mild and extreme [submental fat],” Dr. Richard G. Glogau of San Francisco Dermatology and the University of California, San Francisco, said in an interview. He presented the results of the study at the annual meeting of the American Society for Dermatologic Surgery.

Deoxycholic acid gained U.S. approval in April 2015 as the first injectable cytolytic drug to treat moderate to severe convexity or fullness associated with submental fat (SMF) in adults. It is marketed as Kybella.

Because treatment can be tailored based on the amount and thickness of SMF, the study sought to evaluate deoxycholic acid 2 mg/cm² or placebo for up to six treatments 1 month apart in 47 patients with mild SMF and 46 patients with extreme SMF based on Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) scores of 1 (mild) or 4 (extreme).

The predominantly female cohort had an average age of 48 years in the mild SMF group and 51 years in the extreme SMF group and a mean body mass index of 25 kg/m² and 32.5 kg/m², respectively. About 30% of patients in the extreme SMF group had moderate to severe skin laxity compared with about 15% in the mild SMF group.

The mean number of treatment sessions was 4.9 for placebo and 4.2 for deoxycholic acid in the mild SMF group, and 5.6 for placebo and 4.9 for deoxycholic acid in the extreme SMF group.

“I don’t think in the real world that’s our experience,” Dr. Glogau said at the meeting. “People in the mild group get by with much less and, conversely, people at the extreme end would be happy to go on higher than four or five treatments, depending on what size they started with.”

The mean total injection volume across all treatments was 17.2 mL, 13.9 mL, 38.4 mL, and 31.6 mL, respectively, which is consistent with the need for less product in mild SMF.

In the mild SMF group, SMF was reduced by one grade in significantly more patients following deoxycholic acid treatment than placebo as measured with the CR-SMFRS (74.2% vs. 20%), the Patient-Rated SMFRS (67.7% vs. 33.3%), or a composite of the two scales (61.3% vs. 6.7%).

The percentages of patients with extreme SMF achieving a one-grade improvement with deoxycholic acid were even higher: CR-SMFRS (96.4% vs. 26.7%), PR-SMFRS (89.3% vs. 46.7%), or the composite (89.3% vs. 13.3%), said Dr. Glogau.

Moreover, SMF improved by two grades on the composite endpoint in 43% of extreme SMF patients treated with deoxycholic acid vs. 0% given placebo. P values for all comparisons were less than .05.

“To reach a two-grade change in virtually anything you want to study is difficult to achieve, so I think this is a significant landmark that came out of this study,” Dr. Glogau said.

Significantly more deoxycholic acid–treated patients also reported being satisfied with the appearance of their face and chin compared with those given placebo in the mild SMF (80% vs. 46.7%; P less than .05) and extreme SMF (71.4% vs. 0%; P less than .05) groups.

Despite reductions in SMF, skin laxity was unchanged or got only slightly better from baseline in all patients on deoxycholic acid. This is not surprising, because deoxycholic acid exerts its killing effect on fat cells only, not on fibrous septae or the dermis, and skin laxity is a reflection of inherent elasticity in the dermis, together with the fibrous septae in the fat running between skin and muscle, Dr. Glogau explained.

Most adverse events were mild or moderate in severity and transient in nature, he said. Among mild SMF patients, pain was reported in 74% treated with deoxycholic acid vs. 50% with placebo, bruising in 48% vs. 50%, edema in 42% vs. 25%, numbness in 48% vs. 6%, and swelling in 42% vs. 13%. The percentages were generally similar in the extreme SMF group.

“I think the incidence of hematoma and bruising is actually a function of injection technique and numbers out in clinical practice are somewhat lower,” Dr. Glogau observed.

No drug-related serious adverse events were reported. Nerve paresis was reported in two deoxycholic acid–treated patients with mild SMF and resolved without sequelae after 4 days and after 52 days.

Dysphagia was reported in one deoxycholic acid–treated patient with extreme SMF and resolved without sequelae after 2 days.

None of the events precluded patients from receiving additional treatment, even within the 30-day interval, he said, adding that in practice most clinicians are using longer breaks between treatments.

During a discussion of the study, Dr. Glogau said he uses lidocaine to reduce pain and that local anesthesia should be standard with deoxycholic acid injections.

Fellow presenter Dr. Brian Biesman, director of the Nashville (Tenn.) Centre for Laser and Facial Surgery, said that he was injected with deoxycholic acid both with and without local anesthesia and that they’ve used local anesthesia ever since.

“It makes a huge difference from a patient experience standpoint, of being extraordinarily unpleasant without it – and I have a pretty good pain tolerance – to being extraordinarily unremarkable,” Dr. Biesman said.

Session moderator Dr. Wendy Roberts of Dermatology Rancho Mirage (Calif.), said that Dr. Glogau’s study provides clinicians with data to support deoxycholic acid use in a broader range of patients.

“Now we have a real resource that we can reference and say as a matter of fact, for mild submental fullness you will get a result and this is the study. So you’re not wasting your money, you’re not wasting your time,” she said in an interview. “I think it’s extremely important. In Southern California where I practice, people don’t want to get to be moderate to severe.”

The oral abstract session included several other deoxycholic acid presentations including long-term follow-up from phase II/III trials showing that improvements in SMF severity are maintained for up to 4 years after treatment. The improvements were due to deoxycholic acid treatment, as body weight did not significantly change throughout the follow-up period, said study author Dr. Ashish Bhatia of the DuPage Medical Group, in Naperville, Ill.

Dr. Kenneth Beer of Palm Beach (Fla.) Cosmetic, provided details on the ongoing Kythera-sponsored CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry study looking at how SMF is treated in clinical practice and the risks and benefits associated with treatment.

Kythera Biopharmaceuticals markets Kybella, which is also known as ATX-101. Dr. Glogau, Dr. Roberts, Dr. Bhatia, and Dr. Beer reported ties to Kythera. Several coauthors also disclosed ties to the company.

pwendling@frontlinemedcom.com