Tx Axillary Hyperhidrosis 1210nm Diode Laser

Status Enrolling by invitation

Clinical Trial Summary

Primary axillary hyperhidrosis is a common idiopathic disorder of the eccrine sweat glands that interferes with daily activities and causes significant social distress. This pilot study is designed to evaluate the efficacy and histologic effects of the 1210nm diode laser for the treatment of axillary hyperhidrosis. Initial results may inform the design of an anticipated larger prospective controlled trial. Study participants will receive one laser treatment to one randomly-assigned axilla using the 1210 nm diode laser, and two treatments to the opposite axilla. Changes in sweating will be measured both by quantitative gravimetric analysis of sweat production and by expert panel evaluation of photographs of the starch-iodine test performed on each axilla. Participants will also be asked to subjectively classify the severity of their axillary sweating. These measures will be performed at pretreatment and at one, three, and six months following treatment. Biopsies of both axillae will be done before and two weeks after treatment to assess histologic changes to the eccrine gland and surrounding structures. Treatment of axillary hyperhidrosis with the 1210nm diode laser is a novel approach based on the unique absorption characteristics of this wavelength. We hypothesize that selective heating of lipids at the appropriate tissue level will impact adjacent eccrine glands typically seated at the dermo-hypodermal junction, leading to subjective and/or objective decreases in eccrine secretions. This type of treatment may offer an effective, non-invasive and safe alternative to current treatment modalities.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02105753
Study type	Interventional
Source	United States Naval Medical Center, San Diego
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	October 2013
Completion date	December 2015

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See also
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