Clinical trial NCT00931359: Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Official title: A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Focal Hyperhidrosis, Axilla
Keywords: axillary
hyperhidrosis
primary focal
Lead sponsor: Miramar Labs
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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"). 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
timeFrame: 30 days post-treatment
Secondary outcomes:
measure: Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
timeFrame: 6 months post-treatment
measure: Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
timeFrame: 12 months
measure: Percentage of Subjects With Reported Adverse Events
timeFrame: 6 months post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Sunnyvale
country: United States
facility: Bay Area Center for Plastic Surgery
state: California
city: Metairie
country: United States
facility: The Coleman Clinic
state: Louisiana
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: St. Louis
country: United States
facility: St Louis University
state: Missouri
city: Verona
country: United States
facility: The Dermatology Group
state: New Jersey
Study officials:
affiliation: St. Louis University
name: Dee Anna Glaser, MD
role: PRINCIPAL_INVESTIGATOR
References: