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

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01810991
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.9

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 Laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nd:YAG Laser Nd:YAG 1440nm Laser	Device: Nd:YAG Laser; Nd:YAG 1440nm Laser

Outcome Measures

Primary Outcome Measures

1. Percentage of Photographs Identified Accurately [3 Month Follow Up]

   3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

2. Percentage of Photographs Identified Accurately [6 Month Follow Up]

   3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

Secondary Outcome Measures

1. Number of Participants With Changed and Unchanged Glands on Biopsy Sampling [up to 3 months post last treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juva Skin and Laser Center	New York	New York	United States	10021

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: NCT01810991
• Other Study ID Numbers: CYN12-1440-BK-HID1
• First Posted: Mar 14, 2013
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Hyperhidrosis

Study Results

Participant Flow

Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Multiwavelength Diode Laser Using 1440nm Wavelength. A Rep Rate of 25 Hz was used. Each subject received 1 treatment using this laser.
Period Title: Overall Study
STARTED	19
COMPLETED	17
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Overall Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	13 68.4%
Male	6 31.6%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 5.3%
African American	2 10.5%
African American/Caucasian	1 5.3%
Hispanic	0 0%
Caucasian	15 78.9%
Fitzpatrick Skin Score (Count of Participants)
Fitzpatrick Skin Type I	2 10.5%
Fitzpatrick Skin Type II	8 42.1%
Fitzpatrick Skin Type III	7 36.8%
Fitzpatrick Skin Type IV	1 5.3%
Fitzpatrick Skin Type V	1 5.3%
Fitzpatrick Skin Type VI	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The subject was lost to follow up (not due to adverse events).

Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Measure Participants	18
Mean (Standard Deviation) [% of photographs identified correctly]	84.8 (5.9)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Anything beyond the 3 month follow up was not required, and the subject chose not to come in.

Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Measure Participants	17
Mean (Standard Deviation) [% of photographs identified correctly]	87.2 (12.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The biopsy portion of the study was optional, so there were only 5 subjects.

Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Measure Participants	5
# of Participants with Only Unchanged Glands	3 15.8%
# of Participants with Changed Glands	2 10.5%

Adverse Events

Time Frame	Adverse events were collected for the study duration, around 12 months.
Arm/Group Title	Nd:YAG Laser
Arm/Group Description	Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
All Cause Mortality
	Nd:YAG Laser
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	Nd:YAG Laser
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Nd:YAG Laser
	Affected / at Risk (%)	# Events
Total	19/19 (100%)
Nervous system disorders
Numbness	18/19 (94.7%)
Pain	19/19 (100%)
Skin and subcutaneous tissue disorders
Redness	18/19 (94.7%)
Swelling	18/19 (94.7%)
Bruising	19/19 (100%)
Itching	15/19 (78.9%)
Nodule	0/19 (0%)
Blister	1/19 (5.3%)
Hardness	0/19 (0%)

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.