Microwave Technology Outlasts Botulinum Toxin for Hyperhidrosis

Microwave technology is a new hyperhidrosis treatment that offers longer-term efficacy than botulinum toxin.

"With microwave thermolysis, we now have a reliable and safe method with long-term efficacy to treat our patients who suffer from hyperhidrosis," said Dr. Michael S. Kaminer, at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

A hyperhidrosis diagnosis is made in patients who have visible, excessive sweating for at least 6 months without apparent cause, and with at least two of the following characteristics (J. Am. Acad. Dermatol. 2004;51:274-86):

• Impairs daily activities.

• Frequency of at least one episode per week.

• Bilateral and symmetric.

• Age of onset before 25 years.

• Positive family history.

• Cessation during sleep.

In the United states, approximately 7.6 million people, or 4% of all U.S. adults, are estimated to have axillary hyperhidrosis with a level on the Hyperhidrosis Disease Severity Scale (HDSS) of either 3 ("My sweating is barely tolerable and frequently interferes with my daily activities.") or 4 ("My sweating is intolerable and always interferes with my daily activities."), according to Dr. Kaminer, managing partner, SkinCare Physicians, Chestnut Hill, Mass. Another 32.5 million are "sweat bothered," with an HDSS level of 2 ("My sweating is tolerable but sometimes interferes with my daily activities.") or 1 ("My sweating is never noticeable and never interferes with my daily activities.").

Axillary hyperhidrosis causes considerable distress among patients. In one survey of the Dermatology Life Quality Index, the condition scored just below atopic dermatitis, close to psoriasis, and above acne vulgaris in terms of quality of life impairment, with a mean baseline score of 10.45, compared with 11.20 for atopic dermatitis, 10.53 for psoriasis, and 7.45 for acne vulgaris (Br. J. Dermatol. 2008;159:997-1035).

Current treatment options include various topical over-the-counter products, iontophoresis, sympathectomy, botulinum toxin, ultrasound (in early trials), and now microwave thermolysis.

The proprietary microwave thermolysis system, MiraDry (Miramar Labs), focuses energy delivery to the dermal-fat interface. Microwave energy is absorbed by electric dipoles. The ion content of sweat is a perfect target for this, said Dr. Kaminer, who is also with the departments of dermatology at Yale University, New Haven, Conn.; Dartmouth College, Hanover, N.H.; and Brown University, Providence, R.I.

Energy becomes concentrated along this interface and creates a focal energy zone. Continuous hydroceramic cooling prevents thermal conduction of heat superficially, and creates a heat zone at the level of sweat glands resulting in thermolysis. The procedure involves injectable local anesthesia. Treatment time is about 30 minutes, with rapid recovery.

Long-term efficacy of the device was demonstrated in the DRIUP study (Dermatologic Reduction in Underarm Perspiration), in which 120 patients with HDSS scores of 3 or 4 were randomized in a 2:1 ratio to one to three active treatments (using a prior investigational version of the microwave device) or sham treatment at seven U.S. sites. Efficacy, defined as patients reporting a reduction to an HDSS score of 1 or 2, was 89% at 30 days, 74% at 3 months, 67% at 6 months, and 69% at the 9- and 12-month visits. In the sham group, efficacy was 54% at 30 days and 44% for the 3- and 6-month visits. At all time points, the differences between the treatment and sham groups were significant.

There were 45 treatment-related adverse events, with 28% of the treatment group and 13% of the sham group patients experiencing at least one adverse event. The most common of these was an area of transient altered sensation in the arm, occurring in 10% of patients in the active treatment group. All but one adverse event resolved over time; the patient withdrew from the study, reporting altered sweating on the face. In all, 71% of the events were rated as mild in severity and didn’t affect patients’ daily activities (Dermatol Surg. 2012;38:185-91). Swelling was common, self-limited, and proportional to the energy delivered, Dr. Kaminer noted.

When compared with botulinum toxin, both approaches are effective, noninvasive (injections only), and involve minimal to no downtime. However, the duration of effect is 6.7 months for botulinum toxin, compared with stable efficacy beginning at 3 months and lasting through 12 months follow-up for microwave thermolysis, he said.

Overall, the advantages of microwave thermolysis over other treatments are its long-term efficacy (greater than 12 months, and likely longer), and its efficacy in more than 90% of patients with the latest-generation device. Disadvantages include the need for two procedures and the less than 100% responder rate. Botulinum toxin, in contrast, is easier to perform, and nearly 100% effective. However, it has the downside of the need for repeat treatments approximately every 6 months, and its cost, along with problematic insurance coverage.

Dr. Kaminer said that his practice participated in a registry-type study in the summer and fall of 2011 and was one of the first clinics in the country to purchase a MiraDry System, in December 2011. "Our staff has found the procedure easy to incorporate into the flow of our practice, and patients have found it to be rather easy to have done. We have seen some modest swelling for up to 1 week after treatment, but that is expected. So far, our experience has been pretty much what we would have expected, and if anything, a little better."

He added that, "Interest in offering this new treatment option to patients with excessive underarm sweating has been extremely high. Between clinics in Japan and the U.S., there have been over 1,500 patients treated."

In all, safety results have been consistent with prior experiences. "As with any procedure that we do, it is important to clearly communicate with the patients what to expect from the procedure and the recovery. Our feedback allowed the company to fine-tune their training program so that clinics that purchase the system have tools they can use to make the experience a very positive one for their patients."

Miramar is in the early stages of commercialization for the MiraDry system. It is being placed in a controlled strategy and is expected to reach "a significant number of practices across the U.S. by the middle of this year," he said.

Dr. Kaminer is chairman of the Miramar Labs scientific advisory board. His institution served as a research study site for the phase II study. SDEF and this news organization are owned by Elsevier.

Microwave technology is a new hyperhidrosis treatment that offers longer-term efficacy than botulinum toxin.

"With microwave thermolysis, we now have a reliable and safe method with long-term efficacy to treat our patients who suffer from hyperhidrosis," said Dr. Michael S. Kaminer, at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

A hyperhidrosis diagnosis is made in patients who have visible, excessive sweating for at least 6 months without apparent cause, and with at least two of the following characteristics (J. Am. Acad. Dermatol. 2004;51:274-86):

• Impairs daily activities.

• Frequency of at least one episode per week.

• Bilateral and symmetric.

• Age of onset before 25 years.

• Positive family history.

• Cessation during sleep.

In the United states, approximately 7.6 million people, or 4% of all U.S. adults, are estimated to have axillary hyperhidrosis with a level on the Hyperhidrosis Disease Severity Scale (HDSS) of either 3 ("My sweating is barely tolerable and frequently interferes with my daily activities.") or 4 ("My sweating is intolerable and always interferes with my daily activities."), according to Dr. Kaminer, managing partner, SkinCare Physicians, Chestnut Hill, Mass. Another 32.5 million are "sweat bothered," with an HDSS level of 2 ("My sweating is tolerable but sometimes interferes with my daily activities.") or 1 ("My sweating is never noticeable and never interferes with my daily activities.").

Axillary hyperhidrosis causes considerable distress among patients. In one survey of the Dermatology Life Quality Index, the condition scored just below atopic dermatitis, close to psoriasis, and above acne vulgaris in terms of quality of life impairment, with a mean baseline score of 10.45, compared with 11.20 for atopic dermatitis, 10.53 for psoriasis, and 7.45 for acne vulgaris (Br. J. Dermatol. 2008;159:997-1035).

Current treatment options include various topical over-the-counter products, iontophoresis, sympathectomy, botulinum toxin, ultrasound (in early trials), and now microwave thermolysis.

The proprietary microwave thermolysis system, MiraDry (Miramar Labs), focuses energy delivery to the dermal-fat interface. Microwave energy is absorbed by electric dipoles. The ion content of sweat is a perfect target for this, said Dr. Kaminer, who is also with the departments of dermatology at Yale University, New Haven, Conn.; Dartmouth College, Hanover, N.H.; and Brown University, Providence, R.I.

Energy becomes concentrated along this interface and creates a focal energy zone. Continuous hydroceramic cooling prevents thermal conduction of heat superficially, and creates a heat zone at the level of sweat glands resulting in thermolysis. The procedure involves injectable local anesthesia. Treatment time is about 30 minutes, with rapid recovery.

Long-term efficacy of the device was demonstrated in the DRIUP study (Dermatologic Reduction in Underarm Perspiration), in which 120 patients with HDSS scores of 3 or 4 were randomized in a 2:1 ratio to one to three active treatments (using a prior investigational version of the microwave device) or sham treatment at seven U.S. sites. Efficacy, defined as patients reporting a reduction to an HDSS score of 1 or 2, was 89% at 30 days, 74% at 3 months, 67% at 6 months, and 69% at the 9- and 12-month visits. In the sham group, efficacy was 54% at 30 days and 44% for the 3- and 6-month visits. At all time points, the differences between the treatment and sham groups were significant.

There were 45 treatment-related adverse events, with 28% of the treatment group and 13% of the sham group patients experiencing at least one adverse event. The most common of these was an area of transient altered sensation in the arm, occurring in 10% of patients in the active treatment group. All but one adverse event resolved over time; the patient withdrew from the study, reporting altered sweating on the face. In all, 71% of the events were rated as mild in severity and didn’t affect patients’ daily activities (Dermatol Surg. 2012;38:185-91). Swelling was common, self-limited, and proportional to the energy delivered, Dr. Kaminer noted.

When compared with botulinum toxin, both approaches are effective, noninvasive (injections only), and involve minimal to no downtime. However, the duration of effect is 6.7 months for botulinum toxin, compared with stable efficacy beginning at 3 months and lasting through 12 months follow-up for microwave thermolysis, he said.

Overall, the advantages of microwave thermolysis over other treatments are its long-term efficacy (greater than 12 months, and likely longer), and its efficacy in more than 90% of patients with the latest-generation device. Disadvantages include the need for two procedures and the less than 100% responder rate. Botulinum toxin, in contrast, is easier to perform, and nearly 100% effective. However, it has the downside of the need for repeat treatments approximately every 6 months, and its cost, along with problematic insurance coverage.

Dr. Kaminer said that his practice participated in a registry-type study in the summer and fall of 2011 and was one of the first clinics in the country to purchase a MiraDry System, in December 2011. "Our staff has found the procedure easy to incorporate into the flow of our practice, and patients have found it to be rather easy to have done. We have seen some modest swelling for up to 1 week after treatment, but that is expected. So far, our experience has been pretty much what we would have expected, and if anything, a little better."

He added that, "Interest in offering this new treatment option to patients with excessive underarm sweating has been extremely high. Between clinics in Japan and the U.S., there have been over 1,500 patients treated."

In all, safety results have been consistent with prior experiences. "As with any procedure that we do, it is important to clearly communicate with the patients what to expect from the procedure and the recovery. Our feedback allowed the company to fine-tune their training program so that clinics that purchase the system have tools they can use to make the experience a very positive one for their patients."

Miramar is in the early stages of commercialization for the MiraDry system. It is being placed in a controlled strategy and is expected to reach "a significant number of practices across the U.S. by the middle of this year," he said.

Dr. Kaminer is chairman of the Miramar Labs scientific advisory board. His institution served as a research study site for the phase II study. SDEF and this news organization are owned by Elsevier.

Microwave technology is a new hyperhidrosis treatment that offers longer-term efficacy than botulinum toxin.

"With microwave thermolysis, we now have a reliable and safe method with long-term efficacy to treat our patients who suffer from hyperhidrosis," said Dr. Michael S. Kaminer, at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

A hyperhidrosis diagnosis is made in patients who have visible, excessive sweating for at least 6 months without apparent cause, and with at least two of the following characteristics (J. Am. Acad. Dermatol. 2004;51:274-86):

• Impairs daily activities.

• Frequency of at least one episode per week.

• Bilateral and symmetric.

• Age of onset before 25 years.

• Positive family history.

• Cessation during sleep.

In the United states, approximately 7.6 million people, or 4% of all U.S. adults, are estimated to have axillary hyperhidrosis with a level on the Hyperhidrosis Disease Severity Scale (HDSS) of either 3 ("My sweating is barely tolerable and frequently interferes with my daily activities.") or 4 ("My sweating is intolerable and always interferes with my daily activities."), according to Dr. Kaminer, managing partner, SkinCare Physicians, Chestnut Hill, Mass. Another 32.5 million are "sweat bothered," with an HDSS level of 2 ("My sweating is tolerable but sometimes interferes with my daily activities.") or 1 ("My sweating is never noticeable and never interferes with my daily activities.").

Axillary hyperhidrosis causes considerable distress among patients. In one survey of the Dermatology Life Quality Index, the condition scored just below atopic dermatitis, close to psoriasis, and above acne vulgaris in terms of quality of life impairment, with a mean baseline score of 10.45, compared with 11.20 for atopic dermatitis, 10.53 for psoriasis, and 7.45 for acne vulgaris (Br. J. Dermatol. 2008;159:997-1035).

Current treatment options include various topical over-the-counter products, iontophoresis, sympathectomy, botulinum toxin, ultrasound (in early trials), and now microwave thermolysis.

The proprietary microwave thermolysis system, MiraDry (Miramar Labs), focuses energy delivery to the dermal-fat interface. Microwave energy is absorbed by electric dipoles. The ion content of sweat is a perfect target for this, said Dr. Kaminer, who is also with the departments of dermatology at Yale University, New Haven, Conn.; Dartmouth College, Hanover, N.H.; and Brown University, Providence, R.I.

Energy becomes concentrated along this interface and creates a focal energy zone. Continuous hydroceramic cooling prevents thermal conduction of heat superficially, and creates a heat zone at the level of sweat glands resulting in thermolysis. The procedure involves injectable local anesthesia. Treatment time is about 30 minutes, with rapid recovery.

Long-term efficacy of the device was demonstrated in the DRIUP study (Dermatologic Reduction in Underarm Perspiration), in which 120 patients with HDSS scores of 3 or 4 were randomized in a 2:1 ratio to one to three active treatments (using a prior investigational version of the microwave device) or sham treatment at seven U.S. sites. Efficacy, defined as patients reporting a reduction to an HDSS score of 1 or 2, was 89% at 30 days, 74% at 3 months, 67% at 6 months, and 69% at the 9- and 12-month visits. In the sham group, efficacy was 54% at 30 days and 44% for the 3- and 6-month visits. At all time points, the differences between the treatment and sham groups were significant.

There were 45 treatment-related adverse events, with 28% of the treatment group and 13% of the sham group patients experiencing at least one adverse event. The most common of these was an area of transient altered sensation in the arm, occurring in 10% of patients in the active treatment group. All but one adverse event resolved over time; the patient withdrew from the study, reporting altered sweating on the face. In all, 71% of the events were rated as mild in severity and didn’t affect patients’ daily activities (Dermatol Surg. 2012;38:185-91). Swelling was common, self-limited, and proportional to the energy delivered, Dr. Kaminer noted.

When compared with botulinum toxin, both approaches are effective, noninvasive (injections only), and involve minimal to no downtime. However, the duration of effect is 6.7 months for botulinum toxin, compared with stable efficacy beginning at 3 months and lasting through 12 months follow-up for microwave thermolysis, he said.

Overall, the advantages of microwave thermolysis over other treatments are its long-term efficacy (greater than 12 months, and likely longer), and its efficacy in more than 90% of patients with the latest-generation device. Disadvantages include the need for two procedures and the less than 100% responder rate. Botulinum toxin, in contrast, is easier to perform, and nearly 100% effective. However, it has the downside of the need for repeat treatments approximately every 6 months, and its cost, along with problematic insurance coverage.

Dr. Kaminer said that his practice participated in a registry-type study in the summer and fall of 2011 and was one of the first clinics in the country to purchase a MiraDry System, in December 2011. "Our staff has found the procedure easy to incorporate into the flow of our practice, and patients have found it to be rather easy to have done. We have seen some modest swelling for up to 1 week after treatment, but that is expected. So far, our experience has been pretty much what we would have expected, and if anything, a little better."

He added that, "Interest in offering this new treatment option to patients with excessive underarm sweating has been extremely high. Between clinics in Japan and the U.S., there have been over 1,500 patients treated."

In all, safety results have been consistent with prior experiences. "As with any procedure that we do, it is important to clearly communicate with the patients what to expect from the procedure and the recovery. Our feedback allowed the company to fine-tune their training program so that clinics that purchase the system have tools they can use to make the experience a very positive one for their patients."

Miramar is in the early stages of commercialization for the MiraDry system. It is being placed in a controlled strategy and is expected to reach "a significant number of practices across the U.S. by the middle of this year," he said.

Dr. Kaminer is chairman of the Miramar Labs scientific advisory board. His institution served as a research study site for the phase II study. SDEF and this news organization are owned by Elsevier.