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

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
miraDry
Nd:YAG Laser
Botox®
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sasaki Advanced Aesthetic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Botox®

miraDry®

Nd: YAG laser

Arm Description

Botox®

miraDry®

Nd: YAG laser 1440nm

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2012
Last Updated
December 28, 2020
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01811004
Brief Title
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox®
Arm Type
Experimental
Arm Description
Botox®
Arm Title
miraDry®
Arm Type
Experimental
Arm Description
miraDry®
Arm Title
Nd: YAG laser
Arm Type
Experimental
Arm Description
Nd: YAG laser 1440nm
Intervention Type
Device
Intervention Name(s)
miraDry
Intervention Description
miraDry
Intervention Type
Device
Intervention Name(s)
Nd:YAG Laser
Intervention Description
Nd:YAG 1440 nm Laser
Intervention Type
Device
Intervention Name(s)
Botox®
Intervention Description
Botox®
Primary Outcome Measure Information:
Title
Change in Sweating Assessed Using Gravimetry
Description
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.
Time Frame
1 month follow up
Title
Change in Sweating Assessed Using Gravimetry
Description
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.
Time Frame
3 month follow up
Title
Change in Sweating Assessed Using Gravimetry
Description
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.
Time Frame
6 month follow up
Title
Change in Sweating Assessed Using Gravimetry
Description
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.
Time Frame
9 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Krantz
Organizational Affiliation
Cynosure, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sasaki Advanced Aesthetic Medical Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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