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Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nd:YAG 1440 nm laser

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A healthy non-smoking male or female between 18-55 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 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 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
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 Doxycycline

Sites / Locations

Skin Care Physicians

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nd:YAG 1440 nm laser

Arm Description

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. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT02100072

First Posted

March 25, 2014

Last Updated

December 10, 2020

Sponsor

Cynosure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02100072

Brief Title

Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Official Title

Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cynosure, Inc.

4. Oversight

Data Monitoring Committee

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

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nd:YAG 1440 nm laser

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Nd:YAG 1440 nm laser

Primary Outcome Measure Information:

Title

Change in Sweating Assessed Using Gravimetry

Description

Time Frame

Baseline and 3 months post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A healthy non-smoking male or female between 18-55 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 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 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 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 Doxycycline

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

Skin Care Physicians

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

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