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Primary Axillary Hyperhidrosis
Harnessing the power of microwaves, a new device offers a patient-friendly option for the treatment of hyperhidrosis.
By: William P. Coleman, III, MD, W. Patrick Coleman IV, MD, and Kyle M. Coleman, MD
Microwave energy has been harnessed to provide the latest effective treatment of primary axillary hyperhidrosis. The MiraDry proprietary system focuses microwave energy delivery directly to the dermal-fat interface for targeted thermal destruction of sweat glands. Microwaves create heat by causing physical vibration of dipole molecules. Microwave energy has good absorption in tissues with significant water content, such as the dermis and sweat glands, because of their high dipole moments; however, there is poor absorption in the subcutaneous layer because of its low dipole moment.
Axillary hyperhidrosis is a difficult quality of life problem for many individuals. A mail survey in 2002 found 2.8 percent of respondents felt they had excessive or abnormal/unusual sweating (approximately 1.4 percent complained of axillary hyperhidrosis).1 An online survey in 2008 found that 33 percent of adults felt that they have too much underarm sweat but only five percent seek help.2 The impact of axillary hyperhidrosis on the quality of life index (DLQI) has been calculated to be similar to the effects of psoriasis and acne.3 Sufferers complain of social embarrassment, ruined clothes, and an increased tendency to develop skin irritation and infections.
THE TREATMENT OPTIONS
Previous medical and surgical approaches used have had drawbacks. Prescription topical antiperspirants, like aluminum chloride hexahydrate 25%, can stain clothes, irritate skin, and have no lasting benefit; yet, these topical therapies often fail to suppress sweating sufficiently. Oral anticholenergic medications may cause xerostomia, cylcloplegia, mydriasis, as well as bowel and bladder dysfunction. Botulinum toxins, while highly successful, require significant doses every six to eight months, which is prohibitively expensive.4 Surgical excision of the axilla and dermal curettage leave scars and may restrict range of motion. Liposuction of sweat glands has been shown to work well but is invasive. Endoscopic thoracic sympathectomy is invasive and may lead to Horner’s syndrome, pneumothorax, hemothorax, gustatory sweating, and compensatory hyperhidrosis. An effective non-invasive technique is attractive to patients and is a welcome addition to physicians.
MiraDry (microwave thermolysis) is a non-invasive office procedure that received FDA 510(k) clearance in January 2011 for treatment of excessive underarm sweat. This novel device delivers microwave energy to the dermal-fat interface to destroy sweat glands. Continuous hydroceramic cooling prevents thermal conduction of heat superficially and creates a heat zone at the level of sweat glands, resulting in targeted thermolysis.
THE MIRADRY PROCEDURE
The MiraDry procedure is straightforward. The physician identifies the areas of excessive sweating (usually the entire hair bearing area), then a proper sized template is used to mark out a treatment grid. After administering local anesthesia, the operator moves the hand piece from zone to zone in a specified pattern until the entire hyperhidrotic area is treated. Software on the console guides the user through the treatment session so that each zone is treated, but only once. Swelling and bruising are common immediately after treatment and may persist for several days. The procedure typically lasts 60–75 minutes, depending on the size of treatment area. Two procedures (spaced three months apart) are required for optimal results.
Axillary biopsies as early as 11 days post-treatment demonstrate eccrine and apocrine gland cells devoid of nuclei as well as complete cellular necrosis. At six months, histology confirms a complete absence of sweat glands in the treated area.
Studies of the effectiveness and safety of MiraDry have been encouraging. A randomized, blinded sham-controlled IDE study utilizing an investigational device on 120 patients at seven sites resulted in 89 percent of severely hyperhidrotic subjects reaching a level of 1 or 2 on the Hyperhidrosis Disease Severity Scale at one month. Sixty-nine percent maintained this effect at one year.5 Treatment side effects were mild and transitory. The most common complaint was temporary altered sensation in the skin. One subject exited the study with complaint of altered sweating on the face.
In an open-label study of the commercial version of miraDry, over 90 percent of subjects demonstrated a reduction of HDSS to level 1 or 2 at 12 months. The average gravimetric reduction in sweat was 81.7 percent at one year post treatment, and 85.2 percent reported a greater than 5-point reduction in the DLQI. There was a statistically significant reduction in underarm odor based on patient surveys. Many patients reported hair loss in the axilla, which the female subjects appreciated.6 Most patients are satisfied with the treatment. Two treatments three months apart are required to obtain a lasting result. A small number of patients may benefit from a third procedure targeting resistant areas. Although transient, altered sensation in the skin seen in some patients is the most significant potential side effect and appears to be related to the amount of energy delivered as well as to the thickness of the patient’s skin. Very slender patients have a smaller tissue buffer between the treated dermal-fat interface and the underlying sensory nerves and may have a higher chance of experiencing altered sensation. Experienced users recommend decreasing the energy dose on the most peripheral portions of the axilla (especially on the arm side) in individuals with low body fat.
- Strutton DR, Kowalski JW, Glaser DA, et al. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004;51:241-248.
- Harris Interactive survey conducted for The International Hyperhidrosis Society.
- Basra MKA, Fenech R, Gatt RM, et al. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol 2008; 159: 997-1035.
- Lowe NJ, Glaser DA, Eadie N, et al. North American Botox in Primary Axillary Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol. 2007; 56:604-611.
- Glaser DA, Coleman WP III , Fan LK, et al. A Randomized, Blinded Clinical Evaluation of a Novel Microwave Device for Treating Axillary Hyperhidrosis: The Dermatologic Reduction in Underarm Perspiration Study. Dermatol. Surg. 2012; 38: 185-191.
- Hong HC, Lupin M, O’Shaughnessy KF. Clinical Evaluation of a Microwave Device for Treating Axillary Hyperhidrosis. Dermatol Surg. 2012 (accepted for publication)