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

NCT01810991 | Completed Results

• 1 other identifier: CYN12-1440-BK-HID1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Photographs Identified Accurately

  3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

  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.

  6 Month Follow Up

Secondary Outcomes (1)

• Number of Participants With Changed and Unchanged Glands on Biopsy Sampling

  up to 3 months post last treatment

Study Arms (1)

Nd:YAG Laser

EXPERIMENTAL

Nd:YAG 1440nm Laser

Device: Nd:YAG Laser

Interventions

Nd:YAG Laser DEVICE

Nd:YAG 1440nm Laser

Nd:YAG Laser

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Juva Skin and Laser Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: March 14, 2013
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 4, 2021
• Results First Posted: December 10, 2020

Record last verified: 2021-02

Locations

US (1)