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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Device: Nd:YAG Laser; Device: Botox®; Device: miraDry

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Sasaki Advanced Aesthetic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A healthy non-smoking male or female between 18-70 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox®	Device: Nd:YAG Laser; Nd:YAG 1440 nm Laser; Device: Botox®; Botox®
Experimental: miraDry®	Device: Nd:YAG Laser; Nd:YAG 1440 nm Laser; Device: miraDry; miraDry
Experimental: Nd: YAG laser; Nd: YAG laser 1440nm	Device: Nd:YAG Laser; Nd:YAG 1440 nm Laser

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

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

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): January 22, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: CYN12-GS-HH01