Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100072
• Other study ID #: CYN13-MK-HH01
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: April 2015

Study information

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

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• A healthy non-smoking male or female between 18-55 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 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 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

• 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 Doxycycline

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Device:
• Nd:YAG 1440 nm laser

Locations

Country	Name	City	State
United States	Skin Care Physicians	Chestnut Hill	Massachusetts

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. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline.	Baseline and 3 months post baseline