Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

NCT02100072 | Completed Results

• 1 other identifier: CYN13-MK-HH01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline.

  Baseline and 3 months post baseline

Study Arms (1)

Nd:YAG 1440 nm laser

EXPERIMENTAL

Device: Nd:YAG 1440 nm laser

Interventions

Nd:YAG 1440 nm laser DEVICE

Nd:YAG 1440 nm laser

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy non-smoking male or female between 18-55 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)

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 31, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 8, 2021
• Results First Posted: December 11, 2020

Record last verified: 2020-12

Locations

US (1)