Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Device: miraDry
* Device: Nd:YAG Laser
* Device: Botox®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A healthy non-smoking male or female between 18-70 years of age Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits Clinically diagnosed for primary hyperhidrosis of the axilla. A self-assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4) a. Gravimetric >50mg/5min in each axilla Exclusion Criteria: Clinical diagnosis of secondary hyperhidrosis Uncontrolled systemic disease or infection Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants Receipt of Botox® or Dysport® within the past six months Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed. Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except OTC antiperspirant or planning to use such agents during the course of the study. Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study Is susceptible to light induced seizures or history of seizures Has a history of keloid formation Significant cardiovascular disease Bleeding disorders Anti-platelet and anticoagulant medication Sensitivity to lidocaine or epinephrine Pregnancy or planned pregnancy Existing neuromuscular disorders (myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis) Electronic implants Subjects requiring supplemental oxygen Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity Allergic to Keflex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox®<br>Botox® | Device: Nd:YAG Laser<br>* Nd:YAG 1440 nm Laser<br>Device: Botox®<br>* Botox®<br>|
| Experimental: miraDry®<br>miraDry® | Device: miraDry<br>* miraDry<br>Device: Nd:YAG Laser<br>* Nd:YAG 1440 nm Laser<br>|
| Experimental: Nd: YAG laser<br>Nd: YAG laser 1440nm | Device: Nd:YAG Laser<br>* Nd:YAG 1440 nm Laser<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 1 month follow up | 
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 3 month follow up | 
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 6 month follow up | 
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 9 month follow up |