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Research in Review

Treating Submental Fat

May 2016

Deoxycholic acid (Kybella) is the first and only FDA drug approved to treat submental fat. After undergoing rigorous FDA trials including the use of magnetic resonance imaging studies to image the submental area, the product was approved in April 2015. Since that time it has been adopted by cosmetic physicians who look to sculpt the jawline and decrease submental fat of their patients (Figures 1 and 2).*

 

Deoxycholic acid is supplied in 2-mL vials. Each vial is meant to be a single-use supply and is not supposed to be mixed with any other ingredients such as saline or lidocaine. In practice, many physicians are injecting the product after anesthetizing the patients with lidocaine injections and there does not appear to be any issue with product adverse events or efficacy. It seems probable that injectors will mix the product with lidocaine and/or saline to dilute it if they use the product in nonsubmental regions (Note: Both the dilution and use away from the submental crease are off-label with no data to support them).

Treating Patients

The best candidates for the injections are men and women with mild-moderate submental fat and good skin elasticity. Patients that have lax skin are not good candidates because even after the fat is gone and the fibrosis that follows treatment occurs, there will be loose skin hanging. These people are best treated surgically. For those that have mild-moderate submental fat, injections with deoxycholic acid can have a remarkable impact. Typical injections for these patients use 1 to 2 vials of product per session. Unlike the trial experience, in practice patients can be treated with 3 to 4 sessions in many cases. In my practice, we like to space the injection sessions out between 4 to 6 weeks. In addition, I am starting to use a radiofrequency device in the intervals between sessions with the belief that it helps stimulate collagen formation as well as breakup any potential nodules. Data from a well-thought-out trial would help to determine the efficacy of this added intervention.

In the trials, deoxycholic acid was utilized as a stand-alone product. However, its use with fillers for both the jaw and chin areas seem reasonable. Injections of filler into the mental and jaw areas can be combined with the deoxycholic acid injection to really sculpt the lower one-third of the face in a way that was not available previously. Patients treated in this manner will look more proportional and younger when this is done correctly.

The product is supposed to be injected at intervals of 1 cm using a grid that is provided with the product. When deciding where to inject, it is helpful to mark the lower margin of the mandible and drop down about 1.5 cm from there in order to avoid the marginal mandibular nerve. Injury to this nerve will cause a neuropraxis that results in a crooked smile. Fortunately, this is not permanent and takes about 6 months to resolve. In practice, many physicians will mark the submental crease as their anterior landmark and the lateral aspects of the submental fat as their lateral margins. The inferior margin should not extend below the hyoid but in practice is typically way above that as the fat pad usually is pretty superior. When injecting, it is useful to use the 0.2 mL aliquots in areas with generous fat and taper down to 0.1 mL aliquots in lateral areas that have thin fat. This not only provides a more measured treatment but also saves product for where it is needed.

The postoperative care that these patients require is largely treatment with nonsteroidal anti-inflammatory drugs and managing expectations. If your patients know they are going to swell, they will not be alarmed. When treating with deoxycholic acid, it is a good idea to provide them with a road map outlining what to expect.

Deoxycholic acid is a new tool for cosmetic physicians.  As with any new product, it is likely that treatment will evolve as we learn from our colleagues and we perform more trials. For patients, this product represents an opportunity to treat an area that until now has only been responsive to liposuction or surgery. 

 

Dr Beer is in private practice in West Palm Beach, FL. He is also a volunteer clinical instructor in dermatology at the University of Miami, a consulting associate in the department of medicine at Duke University, and shareholder and director of the Cosmetic Bootcamp meeting. 

 

Disclosure: Dr Beer was an investigator and is a trainer for Kybella. He is an owner of Theraplex LLC, and consults, speaks, or performs clinical trials for Medicis, a division of Valeant, 3M, Sanofi Aventis, Bioform Medical, Allergan, and Stiefel, a GSK company. He is also a shareholder and director of the Cosmetic Bootcamp meeting.

* Photos courtesy of Allergan Inc. 

Deoxycholic acid (Kybella) is the first and only FDA drug approved to treat submental fat. After undergoing rigorous FDA trials including the use of magnetic resonance imaging studies to image the submental area, the product was approved in April 2015. Since that time it has been adopted by cosmetic physicians who look to sculpt the jawline and decrease submental fat of their patients (Figures 1 and 2).*

 

Deoxycholic acid is supplied in 2-mL vials. Each vial is meant to be a single-use supply and is not supposed to be mixed with any other ingredients such as saline or lidocaine. In practice, many physicians are injecting the product after anesthetizing the patients with lidocaine injections and there does not appear to be any issue with product adverse events or efficacy. It seems probable that injectors will mix the product with lidocaine and/or saline to dilute it if they use the product in nonsubmental regions (Note: Both the dilution and use away from the submental crease are off-label with no data to support them).

Treating Patients

The best candidates for the injections are men and women with mild-moderate submental fat and good skin elasticity. Patients that have lax skin are not good candidates because even after the fat is gone and the fibrosis that follows treatment occurs, there will be loose skin hanging. These people are best treated surgically. For those that have mild-moderate submental fat, injections with deoxycholic acid can have a remarkable impact. Typical injections for these patients use 1 to 2 vials of product per session. Unlike the trial experience, in practice patients can be treated with 3 to 4 sessions in many cases. In my practice, we like to space the injection sessions out between 4 to 6 weeks. In addition, I am starting to use a radiofrequency device in the intervals between sessions with the belief that it helps stimulate collagen formation as well as breakup any potential nodules. Data from a well-thought-out trial would help to determine the efficacy of this added intervention.

In the trials, deoxycholic acid was utilized as a stand-alone product. However, its use with fillers for both the jaw and chin areas seem reasonable. Injections of filler into the mental and jaw areas can be combined with the deoxycholic acid injection to really sculpt the lower one-third of the face in a way that was not available previously. Patients treated in this manner will look more proportional and younger when this is done correctly.

The product is supposed to be injected at intervals of 1 cm using a grid that is provided with the product. When deciding where to inject, it is helpful to mark the lower margin of the mandible and drop down about 1.5 cm from there in order to avoid the marginal mandibular nerve. Injury to this nerve will cause a neuropraxis that results in a crooked smile. Fortunately, this is not permanent and takes about 6 months to resolve. In practice, many physicians will mark the submental crease as their anterior landmark and the lateral aspects of the submental fat as their lateral margins. The inferior margin should not extend below the hyoid but in practice is typically way above that as the fat pad usually is pretty superior. When injecting, it is useful to use the 0.2 mL aliquots in areas with generous fat and taper down to 0.1 mL aliquots in lateral areas that have thin fat. This not only provides a more measured treatment but also saves product for where it is needed.

The postoperative care that these patients require is largely treatment with nonsteroidal anti-inflammatory drugs and managing expectations. If your patients know they are going to swell, they will not be alarmed. When treating with deoxycholic acid, it is a good idea to provide them with a road map outlining what to expect.

Deoxycholic acid is a new tool for cosmetic physicians.  As with any new product, it is likely that treatment will evolve as we learn from our colleagues and we perform more trials. For patients, this product represents an opportunity to treat an area that until now has only been responsive to liposuction or surgery. 

 

Dr Beer is in private practice in West Palm Beach, FL. He is also a volunteer clinical instructor in dermatology at the University of Miami, a consulting associate in the department of medicine at Duke University, and shareholder and director of the Cosmetic Bootcamp meeting. 

 

Disclosure: Dr Beer was an investigator and is a trainer for Kybella. He is an owner of Theraplex LLC, and consults, speaks, or performs clinical trials for Medicis, a division of Valeant, 3M, Sanofi Aventis, Bioform Medical, Allergan, and Stiefel, a GSK company. He is also a shareholder and director of the Cosmetic Bootcamp meeting.

* Photos courtesy of Allergan Inc. 

Deoxycholic acid (Kybella) is the first and only FDA drug approved to treat submental fat. After undergoing rigorous FDA trials including the use of magnetic resonance imaging studies to image the submental area, the product was approved in April 2015. Since that time it has been adopted by cosmetic physicians who look to sculpt the jawline and decrease submental fat of their patients (Figures 1 and 2).*

 

Deoxycholic acid is supplied in 2-mL vials. Each vial is meant to be a single-use supply and is not supposed to be mixed with any other ingredients such as saline or lidocaine. In practice, many physicians are injecting the product after anesthetizing the patients with lidocaine injections and there does not appear to be any issue with product adverse events or efficacy. It seems probable that injectors will mix the product with lidocaine and/or saline to dilute it if they use the product in nonsubmental regions (Note: Both the dilution and use away from the submental crease are off-label with no data to support them).

Treating Patients

The best candidates for the injections are men and women with mild-moderate submental fat and good skin elasticity. Patients that have lax skin are not good candidates because even after the fat is gone and the fibrosis that follows treatment occurs, there will be loose skin hanging. These people are best treated surgically. For those that have mild-moderate submental fat, injections with deoxycholic acid can have a remarkable impact. Typical injections for these patients use 1 to 2 vials of product per session. Unlike the trial experience, in practice patients can be treated with 3 to 4 sessions in many cases. In my practice, we like to space the injection sessions out between 4 to 6 weeks. In addition, I am starting to use a radiofrequency device in the intervals between sessions with the belief that it helps stimulate collagen formation as well as breakup any potential nodules. Data from a well-thought-out trial would help to determine the efficacy of this added intervention.

In the trials, deoxycholic acid was utilized as a stand-alone product. However, its use with fillers for both the jaw and chin areas seem reasonable. Injections of filler into the mental and jaw areas can be combined with the deoxycholic acid injection to really sculpt the lower one-third of the face in a way that was not available previously. Patients treated in this manner will look more proportional and younger when this is done correctly.

The product is supposed to be injected at intervals of 1 cm using a grid that is provided with the product. When deciding where to inject, it is helpful to mark the lower margin of the mandible and drop down about 1.5 cm from there in order to avoid the marginal mandibular nerve. Injury to this nerve will cause a neuropraxis that results in a crooked smile. Fortunately, this is not permanent and takes about 6 months to resolve. In practice, many physicians will mark the submental crease as their anterior landmark and the lateral aspects of the submental fat as their lateral margins. The inferior margin should not extend below the hyoid but in practice is typically way above that as the fat pad usually is pretty superior. When injecting, it is useful to use the 0.2 mL aliquots in areas with generous fat and taper down to 0.1 mL aliquots in lateral areas that have thin fat. This not only provides a more measured treatment but also saves product for where it is needed.

The postoperative care that these patients require is largely treatment with nonsteroidal anti-inflammatory drugs and managing expectations. If your patients know they are going to swell, they will not be alarmed. When treating with deoxycholic acid, it is a good idea to provide them with a road map outlining what to expect.

Deoxycholic acid is a new tool for cosmetic physicians.  As with any new product, it is likely that treatment will evolve as we learn from our colleagues and we perform more trials. For patients, this product represents an opportunity to treat an area that until now has only been responsive to liposuction or surgery. 

 

Dr Beer is in private practice in West Palm Beach, FL. He is also a volunteer clinical instructor in dermatology at the University of Miami, a consulting associate in the department of medicine at Duke University, and shareholder and director of the Cosmetic Bootcamp meeting. 

 

Disclosure: Dr Beer was an investigator and is a trainer for Kybella. He is an owner of Theraplex LLC, and consults, speaks, or performs clinical trials for Medicis, a division of Valeant, 3M, Sanofi Aventis, Bioform Medical, Allergan, and Stiefel, a GSK company. He is also a shareholder and director of the Cosmetic Bootcamp meeting.

* Photos courtesy of Allergan Inc. 

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