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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01811004
Other study ID # CYN12-GS-HH01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date July 2015

Study information

Verified date December 2020
Source Cynosure, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 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 OTC 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 Keflex

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Sasaki Advanced Aesthetic Medical Center Pasadena California

Sponsors (1)

Lead Sponsor Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month follow up
Primary 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. 3 month follow up
Primary 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. 6 month follow up
Primary 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. 9 month follow up
See also
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