Primary Focal Hyperhidrosis, Axilla Clinical Trial
— DRI-UPOfficial title:
A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
| Verified date | June 2011 |
| Source | Miramar Labs |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Skin Care Physicians | Chestnut Hill | Massachusetts |
| United States | The Coleman Clinic | Metairie | Louisiana |
| United States | Laser and Skin Surgery Center of Northern California | Sacramento | California |
| United States | Therapeutics Clinical Research | San Diego | California |
| United States | St Louis University | St. Louis | Missouri |
| United States | Bay Area Center for Plastic Surgery | Sunnyvale | California |
| United States | The Dermatology Group | Verona | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Miramar Labs |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
30 days post-treatment | No |
| Secondary | 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 |
6 months post-treatment | No |
| Secondary | 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. |
12 months | No |
| Secondary | 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. | 6 months post-treatment | Yes |