N/A
N=120
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Primary Focal Hyperhidrosis, Axilla
Bottom Line
View on ClinicalTrials.gov: NCT00931359 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. — 54; 89 Percentage of Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DTS-G2 System (Device); DTS System (Sham treatment) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Miramar Labs
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. |
54; 89 | <0.001 sig |
| SECONDARY Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. |
44; 67 | 0.019 sig |
| SECONDARY Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit |
69 | — |
| SECONDARY Percentage of Subjects With Reported Adverse Events |
13; 28 | — |
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
Data sourced from ClinicalTrials.gov (NCT00931359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.