HYPERHIDROSISNCT01810991

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

A study testing Nd:YAG Laser in people with HYPERHIDROSIS, run by Cynosure, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: HYPERHIDROSIS
What is being tested?: Nd:YAG Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Apr 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Juva Skin and Laser Center
New York, New York, 10021

Other trials in United States

About this study

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.

Conditions: HYPERHIDROSIS
Being tested: Nd:YAG Laser
Medical subject headings: Hyperhidrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nd:YAG LaserDevice
Nd:YAG 1440nm Laser

Study groups in NCT01810991
Study group	Role	What they receive
Nd:YAG Laser	Experimental	Nd:YAG 1440nm Laser Receives: Device: Nd:YAG Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Measured: 3 Month Follow Up
Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Measured: 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.
Measured: up to 3 months post last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Apr 2014

First posted14 Mar 2013 (estimated)
Study startJun 2012
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HYPERHIDROSISStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01810991
Sponsor's protocol ID: CYN12-1440-BK-HID1
Status last verified: Feb 2021
First submitted: 6 Dec 2012
Last updated: 4 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
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Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis

All HYPERHIDROSIS trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser
ClinicalTrials.gov ID: NCT01810991
Acronym / sponsor ID: CYN12-1440-BK-HID1
Conditions: HYPERHIDROSIS
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 14 Mar 2013 (estimated)
Results: Posted 10 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nd:YAG Laser	Experimental	Device: Nd:YAG LaserNd:YAG 1440nm Laser

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nd:YAG LaserNd:YAG 1440nm Laser	Device	Nd:YAG Laser

Primary outcome

Percentage of Photographs Identified Accurately
Time frame: 3 Month Follow Up
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Percentage of Photographs Identified Accurately
Time frame: 6 Month Follow Up
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

1 secondary outcome

Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
Time frame: up to 3 months post last treatment

Results and safety

Results posted to the registry on 10 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nd:YAG Laser	19	17

Primary outcome: Percentage of Photographs Identified Accurately

Time frame: 3 Month Follow Up. Mean (Standard Deviation). Unit: % of photographs identified correctly

Measure	Nd:YAG Laser n = 18
Value	84.8 (5.9)

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

Primary outcome: Percentage of Photographs Identified Accurately

Time frame: 6 Month Follow Up. Mean (Standard Deviation). Unit: % of photographs identified correctly

Measure	Nd:YAG Laser n = 17
Value	87.2 (12.3)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the study duration, around 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nd:YAG Laser	0 of 19 (0%)	19 of 19 (100%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for HYPERHIDROSIS

RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
Hyperhidrosis
Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia Krantz study director

Cynosure, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nd:YAG Laser in people with HYPERHIDROSIS, run by Cynosure, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Photographs Identified Accurately (time frame: 3 Month Follow Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01810991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.