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miraDry® Clinical Studies

Microwave Thermolysis of Sweat Glands
Johnson JE, O’Shaughnessy KF, Kim S. Lasers Surg Med. 2012 Jan;44(1):20-5.
PMID: 22127730

BACKGROUND AND OBJECTIVES: Hyperhidrosis is a condition that affects a large
percentage of the population and has a significant impact on peoples’ lives. This report presents a technical overview of a new noninvasive, microwave-based device for creating thermolysis of sweat glands. The fundamental principles of operation of the device are presented, as well as the design and optimization of the device to target the region where the sweat glands reside.
MATERIALS AND METHODS: An applicator was designed that consists of an array of
four waveguide antennas, a cooling system, and a vacuum acquisition system. Initially, the performance of the antenna array was optimized via computer simulation such that microwave absorption was maximized near the dermal/hypodermal interface. Subsequently, hardware was implemented and utilized in pre-clinical testing on a porcine model to optimize the thermal performance and analyze the ability of the system to create thermally affected zones of varying size yet centered on the target region.
RESULTS: Computer simulation results demonstrated absorption profiles at a frequency of 5.8 GHz that had low amounts of absorption at the epidermis and maximal absorption at the dermal/hypodermal interface. The targeted zone was shown to be largely independent of skin thickness. Gross pathological and histological response from pre-clinical testing demonstrated the ability to generate thermally affected zones in the desired target region while providing protection to the upper skin layers.
CONCLUSIONS: The results demonstrate that microwave technology is well suited for
targeting sweat glands while allowing for protection of both the upper skin layers and the structures beneath the subcutaneous fat. Promising initial results from simulation and pre-clinical testing demonstrate the potential of the device as a noninvasive solution for sweat gland thermolysis.

A Randomized, Blinded Clinical Evaluation of a Novel Microwave Device for Treating Axillary Hyperhidrosis: the Dermatologic Reduction in Underarm Perspiration Study
Glaser DA, Coleman WP 3rd, Fan LK, Kaminer MS, Kilmer SL, Nossa R, Smith SR,
O’Shaughnessy KF. Dermatol Surg. 2012 Feb;38(2):185-91.
Department of Dermatology, St. Louis University, St. Louis, Missouri 63104, USA.
PMID: 22289389

BACKGROUND
: Duration of effect and effectiveness limit current options for
treating axillary hyperhidrosis. A new microwave procedure for treatment of
axillary hyperhidrosis has been tested.
STUDY DESIGN/MATERIALS AND METHODS: Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4
and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group).
RESULTS: Thirty days after treatment, the active group had a responder rate of
89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001).
Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when
follow-up ended. Adverse events were generally mild, and all but one resolved
over time.
CONCLUSIONS: The procedure demonstrated statistically significant, long-term
efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

Clinical Evaluation of a Microwave Device for Treating Axillary Hyperhidrosis
Hong HC, Lupin M, O’Shaughnessy KF.
Dermatol Surg. 2012 May;38(5):728-35.
Department of Dermatology and Skin Science, University of British Columbia,
Vancouver, British Columbia, Canada. chihho@interchange.ubc.ca
PMID: 22452511

BACKGROUND
: A third-generation microwave-based device has been developed to treat axillary hyperhidrosis by selectively heating the interface between the skin and
underlying fat where the sweat glands reside.
MATERIALS AND METHODS: Thirty-one (31) adults with primary axillary hyperhidrosis were enrolled. All subjects had one to three procedure sessions over a 6-month period to treat both axillae fully. Efficacy was assessed using the Hyperhidrosis
Disease Severity Scale (HDSS), gravimetric weight of sweat, and the Dermatologic
Life Quality Index (DLQI), a dermatology-specific quality-of-life scale. Subject
safety was assessed at each visit. Subjects were followed for 12 months after all
procedure sessions were complete.
RESULTS: At the 12-month follow-up visit, 90.3% had HDSS scores of 1 or 2, 90.3%
had at least a 50% reduction in axillary sweat from baseline, and 85.2% had a
reduction of at least 5 points on the DLQI. All subjects experienced transient
effects in the treatment area such as swelling, discomfort, and numbness. The
most common adverse event (12 subjects) was the presence of altered sensation in
the skin of the arm that resolved in all subjects.
CONCLUSION: The device tested provided efficacious and durable treatment for
axillary hyperhidrosis.
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