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Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

Primary Purpose

HYPERHIDROSIS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nd:YAG Laser
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 - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A healthy non-smoking male or female between 18-56 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)

Exclusion Criteria:

  • Clinical diagnosis of secondary hyperhidrosis
  • Uncontrolled systemic disease
  • 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 or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study.
  • Allergies to medication or local anesthesia required for the procedure
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  • An intolerance to anesthesia
  • Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  • Taking medications that are photosensitive
  • A history of keloid formation
  • Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study
  • Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study

Sites / Locations

  • Juva Skin and Laser Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nd:YAG Laser

Arm Description

Nd:YAG 1440nm Laser

Outcomes

Primary Outcome Measures

Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

Secondary Outcome Measures

Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape.

Full Information

First Posted
December 6, 2012
Last Updated
February 11, 2021
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01810991
Brief Title
Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (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 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.

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
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nd:YAG Laser
Arm Type
Experimental
Arm Description
Nd:YAG 1440nm Laser
Intervention Type
Device
Intervention Name(s)
Nd:YAG Laser
Intervention Description
Nd:YAG 1440nm Laser
Primary Outcome Measure Information:
Title
Percentage of Photographs Identified Accurately
Description
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Time Frame
3 Month Follow Up
Title
Percentage of Photographs Identified Accurately
Description
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Time Frame
6 Month Follow Up
Secondary Outcome Measure Information:
Title
Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
Description
Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape.
Time Frame
up to 3 months post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A healthy non-smoking male or female between 18-56 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) Exclusion Criteria: Clinical diagnosis of secondary hyperhidrosis Uncontrolled systemic disease 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 or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study. Allergies to medication or local anesthesia required for the procedure A history of thrombophlebitis A history of acute infections A history of heart failure Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment An intolerance to anesthesia Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study Taking medications that are photosensitive A history of keloid formation Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study
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
Juva Skin and Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

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