Axillary HyperhidrosisNCT02105753
Tx Axillary Hyperhidrosis 1210nm Diode Laser
A study testing 1210nm Diode Laser treatments in people with Axillary Hyperhidrosis, run by United States Naval Medical Center, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- 1210nm Diode Laser treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Axillary Hyperhidrosis With a 1210nm Diode Laser
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.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- 1210nm Diode Laser treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1210nm Diode Laser treatmentsDevice
| Study group | Role | What they receive |
|---|---|---|
| 1210nm axillary laser treatments | Experimental | two laser treatments right axilla and one treatment left axilla Receives: Device: 1210nm Diode Laser treatments |
| 1210nm laser treatments to the axilla | Experimental | two laser treatments left axilla and one treatment right axilla Receives: Device: 1210nm Diode Laser treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Candela Corp.
- Responsible party
- Sponsor
- Investigators
- John P. Trafeli, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105753
- Sponsor's protocol ID
- NMCSD.2012.0010
- Status last verified
- Sep 2014
- First submitted
- 2 Apr 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Axillary Hyperhidrosis With a 1210nm Diode Laser
- ClinicalTrials.gov ID
- NCT02105753
- Acronym / sponsor ID
- NMCSD.2012.0010
- Conditions
- Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Candela Corp.
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1210nm axillary laser treatments | Experimental | Device: 1210nm Diode Laser treatmentstwo laser treatments right axilla and one treatment left axilla |
| 1210nm laser treatments to the axilla | Experimental | Device: 1210nm Diode Laser treatmentstwo laser treatments left axilla and one treatment right axilla |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1210nm Diode Laser treatments | Device | 1210nm axillary laser treatments, 1210nm laser treatments to the axilla |
Primary outcome
subjective global assessment questionnaire
Time frame: 7 months
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
Time frame: 7 months
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
Time frame: 7 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P. Trafeli, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1210nm Diode Laser treatments in people with Axillary Hyperhidrosis, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective global assessment questionnaire (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.