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

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.

Study Overview

• Status: Completed
• Conditions: HYPERHIDROSIS
• Intervention / Treatment: Device: Nd:YAG Laser

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Juva Skin and Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nd:YAG Laser; Nd:YAG 1440nm Laser	Device: Nd:YAG Laser; Nd:YAG 1440nm Laser

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

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 14, 2013

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: CYN12-1440-BK-HID1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No