Meeting ID
2961-11
Series ID
2011

Novel Device Uses Cold Therapy to Reduce Forehead Wrinkles

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Novel Device Uses Cold Therapy to Reduce Forehead Wrinkles

GRAPEVINE, TEX. – An investigational cryoprobe device reduced dynamic forehead wrinkles immediately after application in a pilot study of 36 patients that was presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The self-contained, hand-held device, made by MyoScience Inc., uses a 27-gauge needle to deliver cooling to the temporal branch of the facial nerve that controls the frontalis muscle, rather than directly into the muscle as is done with botulinum toxins. The duration of effect is similar to that of botulinum toxins, about 3-4 months.

"Basically, it's a green alternative. There's no chemical, no toxin, it's only cold therapy," principal investigator Dr. Francis Palmer said in an interview.

   Dr. Vic Narurkar

Results from the use of a first-generation version of the device were reported by Dr. Vic Narurkar, who directs the Bay Area Laser Institute in San Francisco. The 36 patients were aged 35-70 years, all with forehead lines during animation. Some were at risk for brow ptosis.

After lidocaine administration, the probe was inserted for 30-45 seconds, and the subsequent reduction in muscle contractility was monitored to see if additional cryoprobe insertions were needed. All patients had immediate dynamic line reduction after two to four cryoprobe insertions, Dr. Narurkar reported.

The most common adverse events were headaches and small focal areas of minor epidermal cold injury, attributed to limitations in the prototype design. No patient experienced ptosis. "Cold has the unique natural property of selectively affecting the axon, yet preserves the endoneurial sheath. ... [It] has no impact on collagen-based structures," Dr. Narurkar explained.

According to Dr. Palmer, both the absence of ptosis risk and the immediacy of the response represent significant advantages over botulinum toxins, for which peak of action is typically 4-7 days following injection.

However, "I don't see this as a replacement for toxin, but as a complement. Physicians now have something to give patients who don't want a toxin, or for use in combination in areas where you can’t use a toxin. Botox is fabulous. It doesn't need to be replaced," said Dr. Palmer, director of the Beverly Hills (Calif.) International Center for Aesthetic Surgery.

Moreover, he noted, at this point, the injection of neurotoxin is easier and somewhat less invasive, although that could change with further revision of the cryoprobe's design. "We think it offers additional things toxin therapy doesn't offer, but it’s in a very early stage. It will be refined further before it hits the market."

MyoScience plans to seek a CE marking for the cryoprobe later this year before approaching the U.S. Food and Drug Administration, he said.

Both Dr. Palmer and Dr. Narurkar are paid consultants for MyoScience, which funded the study.

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GRAPEVINE, TEX. – An investigational cryoprobe device reduced dynamic forehead wrinkles immediately after application in a pilot study of 36 patients that was presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The self-contained, hand-held device, made by MyoScience Inc., uses a 27-gauge needle to deliver cooling to the temporal branch of the facial nerve that controls the frontalis muscle, rather than directly into the muscle as is done with botulinum toxins. The duration of effect is similar to that of botulinum toxins, about 3-4 months.

"Basically, it's a green alternative. There's no chemical, no toxin, it's only cold therapy," principal investigator Dr. Francis Palmer said in an interview.

   Dr. Vic Narurkar

Results from the use of a first-generation version of the device were reported by Dr. Vic Narurkar, who directs the Bay Area Laser Institute in San Francisco. The 36 patients were aged 35-70 years, all with forehead lines during animation. Some were at risk for brow ptosis.

After lidocaine administration, the probe was inserted for 30-45 seconds, and the subsequent reduction in muscle contractility was monitored to see if additional cryoprobe insertions were needed. All patients had immediate dynamic line reduction after two to four cryoprobe insertions, Dr. Narurkar reported.

The most common adverse events were headaches and small focal areas of minor epidermal cold injury, attributed to limitations in the prototype design. No patient experienced ptosis. "Cold has the unique natural property of selectively affecting the axon, yet preserves the endoneurial sheath. ... [It] has no impact on collagen-based structures," Dr. Narurkar explained.

According to Dr. Palmer, both the absence of ptosis risk and the immediacy of the response represent significant advantages over botulinum toxins, for which peak of action is typically 4-7 days following injection.

However, "I don't see this as a replacement for toxin, but as a complement. Physicians now have something to give patients who don't want a toxin, or for use in combination in areas where you can’t use a toxin. Botox is fabulous. It doesn't need to be replaced," said Dr. Palmer, director of the Beverly Hills (Calif.) International Center for Aesthetic Surgery.

Moreover, he noted, at this point, the injection of neurotoxin is easier and somewhat less invasive, although that could change with further revision of the cryoprobe's design. "We think it offers additional things toxin therapy doesn't offer, but it’s in a very early stage. It will be refined further before it hits the market."

MyoScience plans to seek a CE marking for the cryoprobe later this year before approaching the U.S. Food and Drug Administration, he said.

Both Dr. Palmer and Dr. Narurkar are paid consultants for MyoScience, which funded the study.

GRAPEVINE, TEX. – An investigational cryoprobe device reduced dynamic forehead wrinkles immediately after application in a pilot study of 36 patients that was presented at the annual meeting of the American Society for Laser Medicine and Surgery.

The self-contained, hand-held device, made by MyoScience Inc., uses a 27-gauge needle to deliver cooling to the temporal branch of the facial nerve that controls the frontalis muscle, rather than directly into the muscle as is done with botulinum toxins. The duration of effect is similar to that of botulinum toxins, about 3-4 months.

"Basically, it's a green alternative. There's no chemical, no toxin, it's only cold therapy," principal investigator Dr. Francis Palmer said in an interview.

   Dr. Vic Narurkar

Results from the use of a first-generation version of the device were reported by Dr. Vic Narurkar, who directs the Bay Area Laser Institute in San Francisco. The 36 patients were aged 35-70 years, all with forehead lines during animation. Some were at risk for brow ptosis.

After lidocaine administration, the probe was inserted for 30-45 seconds, and the subsequent reduction in muscle contractility was monitored to see if additional cryoprobe insertions were needed. All patients had immediate dynamic line reduction after two to four cryoprobe insertions, Dr. Narurkar reported.

The most common adverse events were headaches and small focal areas of minor epidermal cold injury, attributed to limitations in the prototype design. No patient experienced ptosis. "Cold has the unique natural property of selectively affecting the axon, yet preserves the endoneurial sheath. ... [It] has no impact on collagen-based structures," Dr. Narurkar explained.

According to Dr. Palmer, both the absence of ptosis risk and the immediacy of the response represent significant advantages over botulinum toxins, for which peak of action is typically 4-7 days following injection.

However, "I don't see this as a replacement for toxin, but as a complement. Physicians now have something to give patients who don't want a toxin, or for use in combination in areas where you can’t use a toxin. Botox is fabulous. It doesn't need to be replaced," said Dr. Palmer, director of the Beverly Hills (Calif.) International Center for Aesthetic Surgery.

Moreover, he noted, at this point, the injection of neurotoxin is easier and somewhat less invasive, although that could change with further revision of the cryoprobe's design. "We think it offers additional things toxin therapy doesn't offer, but it’s in a very early stage. It will be refined further before it hits the market."

MyoScience plans to seek a CE marking for the cryoprobe later this year before approaching the U.S. Food and Drug Administration, he said.

Both Dr. Palmer and Dr. Narurkar are paid consultants for MyoScience, which funded the study.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR LASER MEDICINE AND SURGERY

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Major Finding: All patients experienced immediate reduction in wrinkles with two to four cryoprobe insertions.

Data Source: Pilot study of 36 adults (aged 35-70 years) with dynamic forehead wrinkles.

Disclosures: Both Dr. Palmer and Dr. Narurkar are paid consultants for MyoScience, which funded the study.

Nd:YAG Provides Best Outcomes for Mucosal Venous Malformations

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Nd:YAG Provides Best Outcomes for Mucosal Venous Malformations

GRAPEVINE, TEX.  – In a prospective evaluation of 59 children with venous malformations, the long-pulsed neodymium:YAG laser was more effective in treating mucosal venous malformations than lesions on the limbs.

Venous malformations present in many forms that vary in depth, location, and extent, and treatment is largely symptomatic rather than curative. "It is, therefore, important that treatments given are effective in improving the symptoms medium or long term, with as few side effects as possible," said Dr. Stratos Sofos of Alder Hey Children's Hospital in Liverpool, England.

The long-pulsed Nd:YAG laser has become popular for the treatment of small- to medium-size vessels. Its longer pulse duration provides deeper penetration and weaker melanin absorption, allowing it to heat the vessels slowly and uniformly, thus avoiding the vessel rupture with subsequent purpura and hyperpigmentation that can occur with other lasers.

However, published data do not address whether treatment with a long-pulsed Nd:YAG laser provides long-term symptom relief, nor which types of venous malformations respond better than do others, Dr. Sofos said at the annual meeting of the American Society for Laser Medicine and Surgery.

All children who met criteria such as functional impairment, large facial deformities, and painful or bleeding lesions were treated with Candela Corp.'s GentleYAG 1064-nm laser. They received one to three treatments under general anesthesia, delivered in six to eight weekly intervals. Prior to Nd:YAG laser treatment, 32 of the children had received multiple other treatments, including pulsed dye lasers and sclerotherapy.

The 59 patients were aged 2-18 years (mean, 12.3 years). Venous malformations were present on the head and neck in 23, of which 18 (31% of the total) were mucosal. Malformations were on the upper limbs in 15 and on the lower limbs in 18 (total with limb lesions, 56%). The other three had lesions on the chest wall. Average follow up was 24 months (range, 6 months–9 years).

Based on objective assessment, 18% in the upper- and lower-limb group had excellent results and 27% patients had good results, whereas 55% of patients had no change. For the mucosal group, 28% had excellent results, 56% had good results, and 17% had no improvement, Dr. Sofos reported.

The overall complication rate from the Nd:YAG laser treatment was 20% (12 of 59), including skin blistering in 10%, ulceration in 7%, and hypertrophic scarring in 3%. Overall, 83% of the complications occurred in either upper or lower limbs, he noted.

Recurrence was defined by patients for whom symptoms had improved (with good or excellent results) but subsequently recurred. Of the 15 patients who had good or excellent results in the limbs, 4 had a recurrence (recurrence rate, 27%). Of 15 in the mucosa group who had been treated successfully, one had a recurrence (7%).

Subjective and objective evaluation of efficacy correlated well, and the vast majority of patients found the treatment to be successful and would opt to have it again if necessary, Dr. Sofos said.

"Due to the high risk of complications of treatment, however, we feel that treatment should be offered to a [select] group of patients, and should be carried out with caution. Further study will hopefully help us in establishing the best parameters to achieve better results, with minimal complications," he concluded.

This study was funded by the U.K. National Health Service. Dr. Sofos stated that he had no other disclosures.

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GRAPEVINE, TEX.  – In a prospective evaluation of 59 children with venous malformations, the long-pulsed neodymium:YAG laser was more effective in treating mucosal venous malformations than lesions on the limbs.

Venous malformations present in many forms that vary in depth, location, and extent, and treatment is largely symptomatic rather than curative. "It is, therefore, important that treatments given are effective in improving the symptoms medium or long term, with as few side effects as possible," said Dr. Stratos Sofos of Alder Hey Children's Hospital in Liverpool, England.

The long-pulsed Nd:YAG laser has become popular for the treatment of small- to medium-size vessels. Its longer pulse duration provides deeper penetration and weaker melanin absorption, allowing it to heat the vessels slowly and uniformly, thus avoiding the vessel rupture with subsequent purpura and hyperpigmentation that can occur with other lasers.

However, published data do not address whether treatment with a long-pulsed Nd:YAG laser provides long-term symptom relief, nor which types of venous malformations respond better than do others, Dr. Sofos said at the annual meeting of the American Society for Laser Medicine and Surgery.

All children who met criteria such as functional impairment, large facial deformities, and painful or bleeding lesions were treated with Candela Corp.'s GentleYAG 1064-nm laser. They received one to three treatments under general anesthesia, delivered in six to eight weekly intervals. Prior to Nd:YAG laser treatment, 32 of the children had received multiple other treatments, including pulsed dye lasers and sclerotherapy.

The 59 patients were aged 2-18 years (mean, 12.3 years). Venous malformations were present on the head and neck in 23, of which 18 (31% of the total) were mucosal. Malformations were on the upper limbs in 15 and on the lower limbs in 18 (total with limb lesions, 56%). The other three had lesions on the chest wall. Average follow up was 24 months (range, 6 months–9 years).

Based on objective assessment, 18% in the upper- and lower-limb group had excellent results and 27% patients had good results, whereas 55% of patients had no change. For the mucosal group, 28% had excellent results, 56% had good results, and 17% had no improvement, Dr. Sofos reported.

The overall complication rate from the Nd:YAG laser treatment was 20% (12 of 59), including skin blistering in 10%, ulceration in 7%, and hypertrophic scarring in 3%. Overall, 83% of the complications occurred in either upper or lower limbs, he noted.

Recurrence was defined by patients for whom symptoms had improved (with good or excellent results) but subsequently recurred. Of the 15 patients who had good or excellent results in the limbs, 4 had a recurrence (recurrence rate, 27%). Of 15 in the mucosa group who had been treated successfully, one had a recurrence (7%).

Subjective and objective evaluation of efficacy correlated well, and the vast majority of patients found the treatment to be successful and would opt to have it again if necessary, Dr. Sofos said.

"Due to the high risk of complications of treatment, however, we feel that treatment should be offered to a [select] group of patients, and should be carried out with caution. Further study will hopefully help us in establishing the best parameters to achieve better results, with minimal complications," he concluded.

This study was funded by the U.K. National Health Service. Dr. Sofos stated that he had no other disclosures.

GRAPEVINE, TEX.  – In a prospective evaluation of 59 children with venous malformations, the long-pulsed neodymium:YAG laser was more effective in treating mucosal venous malformations than lesions on the limbs.

Venous malformations present in many forms that vary in depth, location, and extent, and treatment is largely symptomatic rather than curative. "It is, therefore, important that treatments given are effective in improving the symptoms medium or long term, with as few side effects as possible," said Dr. Stratos Sofos of Alder Hey Children's Hospital in Liverpool, England.

The long-pulsed Nd:YAG laser has become popular for the treatment of small- to medium-size vessels. Its longer pulse duration provides deeper penetration and weaker melanin absorption, allowing it to heat the vessels slowly and uniformly, thus avoiding the vessel rupture with subsequent purpura and hyperpigmentation that can occur with other lasers.

However, published data do not address whether treatment with a long-pulsed Nd:YAG laser provides long-term symptom relief, nor which types of venous malformations respond better than do others, Dr. Sofos said at the annual meeting of the American Society for Laser Medicine and Surgery.

All children who met criteria such as functional impairment, large facial deformities, and painful or bleeding lesions were treated with Candela Corp.'s GentleYAG 1064-nm laser. They received one to three treatments under general anesthesia, delivered in six to eight weekly intervals. Prior to Nd:YAG laser treatment, 32 of the children had received multiple other treatments, including pulsed dye lasers and sclerotherapy.

The 59 patients were aged 2-18 years (mean, 12.3 years). Venous malformations were present on the head and neck in 23, of which 18 (31% of the total) were mucosal. Malformations were on the upper limbs in 15 and on the lower limbs in 18 (total with limb lesions, 56%). The other three had lesions on the chest wall. Average follow up was 24 months (range, 6 months–9 years).

Based on objective assessment, 18% in the upper- and lower-limb group had excellent results and 27% patients had good results, whereas 55% of patients had no change. For the mucosal group, 28% had excellent results, 56% had good results, and 17% had no improvement, Dr. Sofos reported.

The overall complication rate from the Nd:YAG laser treatment was 20% (12 of 59), including skin blistering in 10%, ulceration in 7%, and hypertrophic scarring in 3%. Overall, 83% of the complications occurred in either upper or lower limbs, he noted.

Recurrence was defined by patients for whom symptoms had improved (with good or excellent results) but subsequently recurred. Of the 15 patients who had good or excellent results in the limbs, 4 had a recurrence (recurrence rate, 27%). Of 15 in the mucosa group who had been treated successfully, one had a recurrence (7%).

Subjective and objective evaluation of efficacy correlated well, and the vast majority of patients found the treatment to be successful and would opt to have it again if necessary, Dr. Sofos said.

"Due to the high risk of complications of treatment, however, we feel that treatment should be offered to a [select] group of patients, and should be carried out with caution. Further study will hopefully help us in establishing the best parameters to achieve better results, with minimal complications," he concluded.

This study was funded by the U.K. National Health Service. Dr. Sofos stated that he had no other disclosures.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR LASER MEDICINE AND SURGERY

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Inside the Article

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Major Finding: Based on objective assessment, 18% in the upper- and lower-limb group had excellent results and 27% of patients had good results, whereas 55% of patients had no change. In the mucosal group, 28% had excellent results, 56% had good results, and 17% had no improvement.

Data Source: Prospective evaluation of 59 children with venous malformations who were seen at a single hospital.

Disclosures: The study was funded by the U.K. National Health Service. Dr. Sofos stated that he had no other disclosures.