HyperhidrosisNCT01811004

Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis

A study testing miraDry, Nd:YAG Laser and Botox® 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.

Official record

Search all trials

Trial summary

The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hyperhidrosis
What is being tested?: miraDry, Nd:YAG Laser and Botox®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jul 2015
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A healthy non-smoking male or female between 18-70 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) a. Gravimetric >50mg/5min in each axilla

Who cannot join

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 OTC antiperspirant or planning to use such agents during the course of the study.

Show all 20Show 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
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 Keflex

Trial locations and contacts

1 site in 1 country.

United States1 site

Sasaki Advanced Aesthetic Medical Center
Pasadena, California, 91105

Other trials in United States

About this study

The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.

Conditions: Hyperhidrosis
Being tested: miraDry, Nd:YAG Laser, Botox®
Medical subject headings: Hyperhidrosis

What participants receive

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

miraDryDevice
miraDry
Nd:YAG LaserDevice
Nd:YAG 1440 nm Laser
Botox®Device
Botox®

Study groups in NCT01811004
Study group	Role	What they receive
Botox®	Experimental	Botox® Receives: Device: Nd:YAG Laser; Device: Botox®
miraDry®	Experimental	miraDry® Receives: Device: miraDry; Device: Nd:YAG Laser
Nd: YAG laser	Experimental	Nd: YAG laser 1440nm Receives: Device: Nd:YAG Laser

What is being measured

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

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.
Measured: 1 month follow up
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.
Measured: 3 month follow up
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.
Measured: 6 month follow up
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.
Measured: 9 month follow up

Timeline

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

Sep 2012Jul 2015

First posted14 Mar 2013 (estimated)
Study startSep 2012
Primary completionJul 2015
Study completionJul 2015

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: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01811004
Sponsor's protocol ID: CYN12-GS-HH01
Status last verified: Dec 2020
First submitted: 6 Dec 2012
Last updated: 22 Jan 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

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

All Hyperhidrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
ClinicalTrials.gov ID: NCT01811004
Acronym / sponsor ID: CYN12-GS-HH01
Conditions: Hyperhidrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 14 Mar 2013 (estimated)
Results: Posted 22 Jan 2021

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 the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Botox®	Experimental	Device: Nd:YAG Laser, Device: Botox®Botox®
miraDry®	Experimental	Device: miraDry, Device: Nd:YAG LasermiraDry®
Nd: YAG laser	Experimental	Device: Nd:YAG LaserNd: YAG laser 1440nm

Who may qualify

Ages: 18 to 70 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 18-70 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) a. Gravimetric >50mg/5min in each axilla

Key exclusion criteria (20 listed)

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.

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
miraDrymiraDry	Device	miraDry®
Nd:YAG LaserNd:YAG 1440 nm Laser	Device	Botox®, Nd: YAG laser, miraDry®
Botox®Botox®	Device	Botox®

Primary outcome

Change in Sweating Assessed Using Gravimetry
Time frame: 1 month follow up
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.
Change in Sweating Assessed Using Gravimetry
Time frame: 3 month follow up
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.
Change in Sweating Assessed Using Gravimetry
Time frame: 6 month follow up
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.
Change in Sweating Assessed Using Gravimetry
Time frame: 9 month follow up
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.

Results and safety

Results posted to the registry on 22 Jan 2021, 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 and miraDry	9	8
Nd: YAG Laser 1440nm and Botox	8	5

Primary outcome: Change in Sweating Assessed Using Gravimetry

Time frame: 1 month follow up. Mean (Standard Deviation). Unit: mg

Measure	Botox® n = 7	miraDry® n = 9	Nd: YAG Laser n = 16
Value	267.91 (432.53)	57.36 (33.55)	155.14 (263.53)

Population analysed: One subject in the Botox treatment was a no-show to their scheduled follow up.

Primary outcome: Change in Sweating Assessed Using Gravimetry

Time frame: 3 month follow up. Mean (Standard Deviation). Unit: mg

Measure	Botox® n = 8	miraDry® n = 9	Nd: YAG Laser n = 17
Value	231.89 (407.42)	53.59 (38.67)	22.72 (31.34)

Primary outcome: Change in Sweating Assessed Using Gravimetry

Time frame: 6 month follow up. Mean (Standard Deviation). Unit: mg

Measure	Botox® n = 8	miraDry® n = 9	Nd: YAG Laser n = 17
Value	223.51 (380.18)	65.93 (46.48)	39.07 (42.11)

Primary outcome: Change in Sweating Assessed Using Gravimetry

Time frame: 9 month follow up. Mean (Standard Deviation). Unit: mg

Measure	Botox® n = 4	miraDry® n = 8	Nd: YAG Laser n = 12
Value	99.49 (81.27)	67.06 (44.3)	28.36 (37.84)

Population analysed: The gravimetric test was not required for the 9 month follow up.

Adverse events

Time frame: Adverse Events occurring were collected throughout the study, around 18 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botox®	0 of 8 (0%)	8 of 8 (100%)	0 of 8
miraDry®	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Nd: YAG Laser	0 of 17 (0%)	17 of 17 (100%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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 miraDry, Nd:YAG Laser and Botox® 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 20 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 22 Jan 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 22 Jan 2021). 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?

Change in Sweating Assessed Using Gravimetry (time frame: 1 month follow up). The study lists 4 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 NCT01811004.

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 22 Jan 2021.