Miradry Treatment for Focal Axillary Hyperhidrosis (MiraDry Tx)
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|ClinicalTrials.gov Identifier: NCT02295891|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Axillary Hyperhidrosis||Device: MiraDry ®||Not Applicable|
To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis.
- To characterize the outcomes of and clinical response to the MiraDry ® treatment system with respect to the aforementioned criteria.
- To compare the results of non-invasive miraDry ® treatment system to the existing surgical correction with respect to the aforementioned criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: MiraDry ® treatment
MiraDry ® is the trademarked name of a non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface.
Each participant will be scheduled two MiraDry ® treatment appointments approximately three months apart.
Device: MiraDry ®
Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface
- Primary effectiveness of the MiraDry treatment system (Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 1 year ]To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Hyperhidrosis Disease Severity Scale (HDSS) as a prescreening survey. The HDSS (below) is a diagnostic tool that qualitatively measures (Likert scaled 1-4) disease-specific severity of the patient's condition based on the degree to which daily activities are impacted. This will be done at baseline, during treatment, at the 6 month follow-up visit, and 1 year follow-up visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295891
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Malcolm Brock, MD||Johns Hopkins University|