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

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02100072
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperhidrosis	Device: Nd:YAG 1440 nm laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nd:YAG 1440 nm laser	Device: Nd:YAG 1440 nm laser

Outcome Measures

Primary Outcome Measures

1. Change in Sweating Assessed Using Gravimetry [Baseline and 3 months post baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skin Care Physicians	Chestnut Hill	Massachusetts	United States	02467

Sponsors and Collaborators

• Cynosure, Inc.

Investigators

• Study Director: Patricia Krantz, Cynosure, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynosure, Inc.
• ClinicalTrials.gov Identifier: NCT02100072
• Other Study ID Numbers: CYN13-MK-HH01
• First Posted: Mar 31, 2014
• Last Update Posted: Jan 8, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Hyperhidrosis

Study Results

Participant Flow

Arm/Group Title	Nd:YAG 1440 nm Laser
Arm/Group Description	Nd:YAG Laser With 1440nm Wavelength. Each subject received 1 treatment using this laser over an approximately 3x4 cm area.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Nd:YAG 1440 nm Laser
Arm/Group Description	Nd:YAG 1440 nm laser
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	3 60%
African American	2 40%
Fitzpatrick Skin Score (Count of Participants)
Fitzpatrick Skin Type I	0 0%
Fitzpatrick Skin Type II	0 0%
Fitzpatrick Skin Type III	3 60%
Fitzpatrick Skin Type IV	0 0%
Fitzpatrick Skin Type V	2 40%
Fitzpatrick Skin Type VI	0 0%

Outcome Measures

1. Primary Outcome

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. 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.
Time Frame	Baseline and 3 months post baseline

Outcome Measure Data

Analysis Population Description

1 subject was incapable of attending the follow up visit, so their gravimetric measurement was not able to be obtained. They were able to answer other follow up questions via the phone, however.

Arm/Group Title	Nd:YAG 1440 nm Laser
Arm/Group Description	Nd:YAG Laser With 1440nm Wavelength. Each subject received 1 treatment using this laser over an approximately 3x4 cm area.
Measure Participants	4
Average Gravimetric Change (Left Side)	-104.50 (156.57)
Average Gravimetric Change (Right Side)	-90.85 (131.84)

Adverse Events

Time Frame	Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Arm/Group Title	Nd:YAG 1440 nm Laser
Arm/Group Description	Nd:YAG 1440 nm laser
All Cause Mortality
	Nd:YAG 1440 nm Laser
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Nd:YAG 1440 nm Laser
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Nd:YAG 1440 nm Laser
	Affected / at Risk (%)	# Events
Total	2/5 (40%)
Nervous system disorders
Numbness	2/5 (40%)
Pain	2/5 (40%)
Skin and subcutaneous tissue disorders
Sweat	1/5 (20%)
Bruising	1/5 (20%)
Itching	1/5 (20%)
Redness	1/5 (20%)
Swelling	1/5 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.