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

NCT ID: NCT02100072

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-04-30

Brief 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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nd:YAG 1440 nm laser

Group Type: EXPERIMENTAL

Nd:YAG 1440 nm laser

Intervention Type: DEVICE

Interventions

Nd:YAG 1440 nm laser

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

CYN13-MK-HH01

Identifier Type: -

Identifier Source: org_study_id