The Food and Drug Administration has cleared miraDry — a microwave-based device already approved for eliminating underarm sweat glands — for the permanent reduction of underarm hair of all colors.
Following the FDA clearance, miraDry maker Miramar Labs, Santa Clara, Calif., announced the roll out of the miraSmooth brand, which targets patients looking to eliminate underarm hair. The miraDry/Smooth system is based on Miramar’s proprietary miraWave technology, which uses precisely controlled microwave energy. It is this technology that enables the elimination of underarm hair regardless of its color. Thus, Miramar is marketing miraDry/Smooth as the only FDA-cleared device for treating unwanted underarm hair of all colors as well as the permanent reduction of underarm sweat.
“MiraSmooth is the use of the miraDry system, in conjunction with laser hair treatment when appropriate, for axillary hair removal,” says Miramar Vice President of Marketing Rob Ellis. “It’s a versatile hair-removal option that can be used alone, or in combination with a series of laser hair-removal treatments, and also provides the unique benefit of simultaneously eliminating sweat. The treatment is quick and simple, takes about one hour and is only available in a physician’s office.”
The FDA clearance of miraDry for hair removal was based on a study performed at three private dermatology clinics. Study co-author Jeremy Brauer, M.D., a dermatologist at the Laser & Skin Surgery Center in New York, tells Cosmetic Surgery Times that the study recruited adult subjects seeking underarm-hair reduction.
“They were screened, and those eligible received up to two sessions, three months apart,” he says. “Fifty-six subjects were enrolled, with an average age of 33 years; 80% of the subjects were female and 88% were Caucasian.”
For the purpose of hair count and blinded physician assessment, photos were taken before each treatment and at each follow-up visit. Subjects gave feedback on their overall satisfaction with the treatment experience, as well as odor rating and sweat ratings, during follow-ups.
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Hair Reduction Results
According to Dr. Brauer, the study provides evidence for safe and effective axillary hair reduction.
“Based on the study, patients can expect at least 70% reduction in one to two treatments,” he says. “However, our study parameters and technique were optimized for sweat reduction, so while the results are promising, I think that they can and will be better once a protocol is defined for hair reduction. We only treated once or twice and evaluated at follow-up visits that were determined at the start of the study — the latter point being that it’s possible hair reduction is observed earlier than we noted.”
As for pain level and after effects, Dr. Brauer says that since local anesthesia is administered prior to treatment, most patients experience little or no discomfort.
“There is a strong safety record with the miraDry procedure,” he says. “After treatments patients may experience temporary swelling, soreness, tingling or numbness. These all resolve in a matter of a few days to weeks.”
Dr. Brauer says the study’s most significant finding was that there were no differences in the reduction of light or dark hair.
“For the first time, there was a device for hair removal that did not depend upon the pigment or color of the hair — essentially making it a ‘color-blind’ procedure,” he tells Cosmetic Surgery Times. “The implications for this are far-reaching: treatment of gray hair or blonde hair, and treatment of individuals of all skin types without the concerns associated with standard hair-removal devices.”
Helen M. Torok, a Medina, Ohio, dermatologist not involved in the study, says she has not used miraDry but knows about it.
“It was exclusively used for hyperhidrosis,” she says, “but during the procedures it was discovered that there was a decrease in hair — and it didn’t matter what hair, which translates to the fact that the energy delivered is deep. It would be nice to see if we can use this technology on the face for hirsutism, but the current device is probably too deep and would cause scarring.”
According to a Mirmar spokesperon, miraSmooth is currently only offered in the United States. The list price of miraDry is $84,450. For physicians who own a miraDry system, there is no additional cost or device required to offer the miraSmooth procedure.
Disclosure: Dr. Brauer served as a consultant to Miramar.