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

NCT01811004 | Completed Results

• 1 other identifier: CYN12-GS-HH01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Botox®

EXPERIMENTAL

Botox®

Device: Nd:YAG Laser; Device: Botox®

miraDry®

EXPERIMENTAL

miraDry®

Device: miraDry; Device: Nd:YAG Laser

Nd: YAG laser

EXPERIMENTAL

Nd: YAG laser 1440nm

Device: Nd:YAG Laser

Interventions

miraDry DEVICE

miraDry

miraDry®

Nd:YAG Laser DEVICE

Nd:YAG 1440 nm Laser

Botox®; Nd: YAG laser; miraDry®

Botox® DEVICE

Botox®

Botox®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: March 14, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

US (1)