CompletedInterventionalNot ApplicableUpdated Mar 4, 2021
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis | NCT01811004 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 22, 2021
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
ClinicalTrials.gov ID
NCT01811004
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
17Actual
Last Update Posted
Jan 22, 2021Actual
Start Date
Sep 2012
Primary Completion Date
Jul 2015Actual
Completion Date
Jul 2015Actual
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.
Hyperhidrosis
miraDry
Nd:YAG Laser
Botox®
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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