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CompletedNCT01810991Updated Mar 4, 2021Results posted

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

An interventional study of Nd:YAG Laser in HYPERHIDROSIS, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Cynosure, Inc. (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HYPERHIDROSIS

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03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

First submitted before Cynosure, Inc. became part of Cynosure Lutronic, Inc..

Browse Cynosure, Inc. studies →All Cynosure Lutronic, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Nd:YAG Laser

    Nd:YAG 1440nm Laser

    Device: Nd:YAG Laser

Interventions

  • DeviceNd:YAG Laser

    Nd:YAG 1440nm Laser

06

What researchers measure

Primary outcomes

  1. Percentage of Photographs Identified Accurately

    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

  2. Percentage of Photographs Identified Accurately

    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 outcomes

  1. 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.

    Time frame: up to 3 months post last treatment

07

Results

Posted Dec 10, 2020

Participant flow

Participant flow — Overall Study
MilestoneNd:YAG Laser
Started19
Completed17
Not completed2

Outcome measures

PrimaryPercentage of Photographs Identified Accurately

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
Reported as:
Mean · % of photographs identified correctly
Percentage of Photographs Identified Accurately
% of photographs identified correctlyNd:YAG Laser
Percentage of Photographs Identified Accurately84.8 ± 5.9
PrimaryPercentage of Photographs Identified Accurately

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
Reported as:
Mean · % of photographs identified correctly
Percentage of Photographs Identified Accurately
% of photographs identified correctlyNd:YAG Laser
Percentage of Photographs Identified Accurately87.2 ± 12.3
SecondaryNumber 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.

Time frame:
up to 3 months post last treatment
Reported as:
Count of participants · Participants
Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
ParticipantsNd:YAG Laser
# of Participants with Only Unchanged Glands3
# of Participants with Changed Glands2

Adverse events

Collected over Adverse events were collected for the study duration, around 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nd:YAG Laser0/19 (0%)0/19 (0%)19/19 (100%)
Most frequent other events
Most frequent other events
EventNd:YAG Laser
PainNervous system disorders19/19
BruisingSkin and subcutaneous tissue disorders19/19
NumbnessNervous system disorders18/19
RednessSkin and subcutaneous tissue disorders18/19
SwellingSkin and subcutaneous tissue disorders18/19
ItchingSkin and subcutaneous tissue disorders15/19
BlisterSkin and subcutaneous tissue disorders1/19
NoduleSkin and subcutaneous tissue disorders0/19
HardnessSkin and subcutaneous tissue disorders0/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Nd:YAG Laser
<=18 years0
Between 18 and 65 years19
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Nd:YAG Laser
Female13
Male6
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nd:YAG Laser
Race/Ethnicity — Asian1
Race/Ethnicity — African American2
Race/Ethnicity — African American/Caucasian1
Race/Ethnicity — Hispanic0
Race/Ethnicity — Caucasian15
Fitzpatrick Skin Score
Fitzpatrick Skin Score(Participants)Nd:YAG Laser
Fitzpatrick Skin Type I2
Fitzpatrick Skin Type II8
Fitzpatrick Skin Type III7
Fitzpatrick Skin Type IV1
Fitzpatrick Skin Type V1
Fitzpatrick Skin Type VI0
08

Study locations

1 site
  • Juva Skin and Laser Center
    New York, New York 10021, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01810991
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Mar 14, 2013
Start date
Jun 2012
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Dec 10, 2020
Last update
Mar 4, 2021

Study contacts

Patricia Krantz
study director · Cynosure, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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