Primary Focal Hyperhidrosis, AxillaDRI-UPNCT00931359
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
A study testing DTS-G2 System in people with Primary Focal Hyperhidrosis, Axilla, run by Miramar Labs at 7 sites in United States.
Trial summary
This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Focal Hyperhidrosis, Axilla
- What is being tested?
- DTS-G2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla
- poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale
- primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria
- female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period
- female subjects over 40 must have had a mammogram in the last 2 years
- subjects must be willing to comply with study visits and requirements
Who cannot join
- subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)
- subject has active infection
- subject is pregnant or lactating
- subject has had prior surgery for axillary hyperhidrosis
- subject has had axillary injections of botulinum toxin A in the last year
- subject has used prescription antiperspirants in the last 14 days or plans to use them during the study period
Show all 12Show fewer
- subject has used oral anticholinergics in the last 4 weeks
- subject is a prisoner or under incarceration
- subject is participating in a another clinical trial (or has in the last 30 days)
- subject has history of cancer (some exceptions)
- subject has a pacemaker or other electronic implant
- subject requires supplemental oxygen
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
The Coleman Clinic
Metairie, Louisiana, 70006
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
Therapeutics Clinical Research
San Diego, California, 92123
St Louis University
St Louis, Missouri, 63104
Bay Area Center for Plastic Surgery
Sunnyvale, California, 94085
The Dermatology Group
Verona, New Jersey, 07044
About this study
Official title: A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).
Subjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.
All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.
- Conditions
- Primary Focal Hyperhidrosis, Axilla
- Being tested
- DTS-G2 System, DTS System (Sham treatment)
- Keywords
- axillary, hyperhidrosis, primary focal
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTS-G2 SystemDevice
Treatment with microwave energy
DTS System (Sham treatment)Device
Sham treatment - no energy is delivered
| Study group | Role | What they receive |
|---|---|---|
| Treatment with DTS-G2 System | Experimental | Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used. Receives: Device: DTS-G2 System |
| Sham treatment | Sham comparator | All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used. Receives: Device: DTS System (Sham treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:
- - My underarm sweating is never noticeable and never interferes with my daily activities
- - My underarm sweating is tolerable but sometimes interferes with my daily activities
- - My underarm sweating is barely tolerable and frequently interferes with my daily activities
- - My underarm sweating is intolerable and always interferes with my daily activities
Measured: 30 days post-treatment
Secondary outcomes (3)
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:
- - My underarm sweating is never noticeable and never interferes with my daily activities
- - My underarm sweating is tolerable but sometimes interferes with my daily activities
- - My underarm sweating is barely tolerable and frequently interferes with my daily activities
- - My underarm sweating is intolerable and always interferes with my daily activities
Measured: 6 months post-treatment
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.
- - My underarm sweating is never noticeable and never interferes with my daily activities
- - My underarm sweating is tolerable but sometimes interferes with my daily activities
- - My underarm sweating is barely tolerable and frequently interferes with my daily activities
- - My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit.
Measured: 12 months
Percentage of Subjects With Reported Adverse Events
Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Focal Hyperhidrosis, AxillaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miramar Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dee Anna Glaser, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931359
- Sponsor's protocol ID
- CP-0003
- Acronym
- DRI-UP
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2009
- Last updated
- 15 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT00931359
- Acronym / sponsor ID
- DRI-UP / CP-0003
- Conditions
- Primary Focal Hyperhidrosis, Axilla
- Keywords
- axillary, hyperhidrosis, primary focal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Miramar LabsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 14 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).
Subjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.
All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with DTS-G2 System | Experimental | Device: DTS-G2 SystemSubjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used. |
| Sham treatment | Sham comparator | Device: DTS System (Sham treatment)All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla
- poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale
- primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria
- female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period
- female subjects over 40 must have had a mammogram in the last 2 years
Key exclusion criteria (12 listed)
- subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)
- subject has active infection
- subject is pregnant or lactating
- subject has had prior surgery for axillary hyperhidrosis
- subject has had axillary injections of botulinum toxin A in the last year
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 |
|---|---|---|
| DTS-G2 SystemTreatment with microwave energy | Device | Treatment with DTS-G2 System |
| DTS System (Sham treatment)Sham treatment - no energy is delivered | Device | Sham treatment |
Primary outcome
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Time frame: 30 days post-treatment
The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors: 1. - My underarm sweating is never noticeable and never interferes with my daily activities 2. - My underarm sweating is tolerable but sometimes interferes with my daily activities 3. - My underarm sweating is barely tolerable and frequently interferes with my daily activities 4. - My underarm sweating is intolerable and always interferes with my daily activities
3 secondary outcomes
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
Time frame: 6 months post-treatment
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
Time frame: 12 months
Percentage of Subjects With Reported Adverse Events
Time frame: 6 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Dee Anna Glaser, MD principal investigator
St. Louis University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTS-G2 System in people with Primary Focal Hyperhidrosis, Axilla, run by Miramar Labs at 7 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. (time frame: 30 days post-treatment). 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 15 Jun 2011.