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

Cynosure

Status

Completed

Conditions

HYPERHIDROSIS

Treatments

Device: Nd:YAG Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT01810991

CYN12-1440-BK-HID1

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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