Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.

Conditions
-----------------
HYPERHIDROSIS

Intervention / Treatment
-----------------
* Device: Nd:YAG Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A healthy non-smoking male or female between 18-56 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) Exclusion Criteria: Clinical diagnosis of secondary hyperhidrosis Uncontrolled systemic disease 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 over the counter 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 or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study. Allergies to medication or local anesthesia required for the procedure A history of thrombophlebitis A history of acute infections A history of heart failure Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment An intolerance to anesthesia Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study Taking medications that are photosensitive A history of keloid formation Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | 3 Month Follow Up | 
| Percentage of Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | 6 Month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape. | up to 3 months post last treatment |