Back to resultsTx Axillary Hyperhidrosis 1210nm Diode Laser
Primary Purpose
Axillary Hyperhidrosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1210nm Diode Laser treatments
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 18 years old, and no older than age 64.
- Subjects must have localized hyperhidrosis only (axillae +/- palms of the hands, soles of the feet, face and other localized areas) without evidence of generalized hyperhidrosis.
- Subjects must be fully informed and read and sign the informed consent.
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects must be willing to allow two biopsies of each axilla.
Exclusion Criteria:
- Subjects must not be younger than age 18 years or older than age 64
- Subjects must not have had previous axillary laser hair reduction nor plan to have laser hair reduction while in the study.
- Subjects must not have had previous surgical treatment of the axillae such as axillary gland excision, liposuction, sympathectomy, or subcutaneous curettage and must be willing to avoid such therapies while in the study.
- Subjects must not have received axillary injections of botulinum toxin nine months prior to treatment and must be willing to avoid such therapies while in the study.
- Subjects must avoid use of depilatories to either axilla during the duration of the study
- Subjects must not have used aluminum chloride within 1 week or had iontophoresis treatment to the axillae one month prior to treatment
- Subjects must not have a history of systemic disease leading to excess sweating including hyperthyroidism and diabetes mellitus
- Subjects must not have active local or systemic infection.
- Subjects must not be immunocompromised.
- Subjects must not be pregnant or nursing. Pregnancy test will be offered initially and before each treatment if subject is not sure of status.
- Active duty military subjects who will be deploying within 7 months after accessioned into the study will be excluded
- Subjects who refuse to sign the informed consent document and/or refuse to comply with all follow-up requirements will be excluded
Subjects must sweat a minimum of 100mg per axillae for men and 50mg per axillae for women
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Sites / Locations
- NMCSD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1210nm axillary laser treatments
1210nm laser treatments to the axilla
Arm Description
two laser treatments right axilla and one treatment left axilla
two laser treatments left axilla and one treatment right axilla
Outcomes
Primary Outcome Measures
subjective global assessment questionnaire
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
gravimetric analysis
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
modified starch-iodine test
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
Secondary Outcome Measures
Full Information
NCT ID
NCT02105753
First Posted
April 2, 2014
Last Updated
February 9, 2015
Sponsor
United States Naval Medical Center, San Diego
Collaborators
Candela Corp.
1. Study Identification
Unique Protocol Identification Number
NCT02105753
Brief Title
Tx Axillary Hyperhidrosis 1210nm Diode Laser
Official Title
Treatment of Axillary Hyperhidrosis With a 1210nm Diode Laser
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
Candela Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1210nm axillary laser treatments
Arm Type
Experimental
Arm Description
two laser treatments right axilla and one treatment left axilla
Arm Title
1210nm laser treatments to the axilla
Arm Type
Experimental
Arm Description
two laser treatments left axilla and one treatment right axilla
Intervention Type
Device
Intervention Name(s)
1210nm Diode Laser treatments
Primary Outcome Measure Information:
Title
subjective global assessment questionnaire
Description
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
Time Frame
7 months
Title
gravimetric analysis
Description
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
Time Frame
7 months
Title
modified starch-iodine test
Description
To evaluate the impact of 1210nm diode laser pulses on sweat output and eccrine gland histology in subjects with axillary hyperhidrosis. Changes in sweat production from a single and double treatment using treatment parameters designed to deliver heat to the dermo-hypodermal junction will be measured. Subjective assessment of outcome will also be measured. The objective and subjective measurement instruments are detailed in the methods section below.Prior to any treatment, baseline level of sweat production will be evaluated with three instruments: A subjective global assessment questionnaire, gravimetric analysis, and the modified starch-iodine test.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 18 years old, and no older than age 64.
Subjects must have localized hyperhidrosis only (axillae +/- palms of the hands, soles of the feet, face and other localized areas) without evidence of generalized hyperhidrosis.
Subjects must be fully informed and read and sign the informed consent.
Subjects must be willing and able to comply with all follow-up requirements.
Subjects must be willing to allow two biopsies of each axilla.
Exclusion Criteria:
Subjects must not be younger than age 18 years or older than age 64
Subjects must not have had previous axillary laser hair reduction nor plan to have laser hair reduction while in the study.
Subjects must not have had previous surgical treatment of the axillae such as axillary gland excision, liposuction, sympathectomy, or subcutaneous curettage and must be willing to avoid such therapies while in the study.
Subjects must not have received axillary injections of botulinum toxin nine months prior to treatment and must be willing to avoid such therapies while in the study.
Subjects must avoid use of depilatories to either axilla during the duration of the study
Subjects must not have used aluminum chloride within 1 week or had iontophoresis treatment to the axillae one month prior to treatment
Subjects must not have a history of systemic disease leading to excess sweating including hyperthyroidism and diabetes mellitus
Subjects must not have active local or systemic infection.
Subjects must not be immunocompromised.
Subjects must not be pregnant or nursing. Pregnancy test will be offered initially and before each treatment if subject is not sure of status.
Active duty military subjects who will be deploying within 7 months after accessioned into the study will be excluded
Subjects who refuse to sign the informed consent document and/or refuse to comply with all follow-up requirements will be excluded
Subjects must sweat a minimum of 100mg per axillae for men and 50mg per axillae for women
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Trafeli, MD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tx Axillary Hyperhidrosis 1210nm Diode Laser
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