Primary Focal Hyperhidrosis, Axilla
Conditions
Keywords
axillary, hyperhidrosis, primary focal
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.
Interventions
DEVICEDTS-G2 System
Treatment with microwave energy
DEVICEDTS System (Sham treatment)
Sham treatment - no energy is delivered
Sponsors
Miramar Labs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. | 6 months 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 |
| Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit | 12 months | The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating. 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 This outcome is only measured for the treatment group; sham group exited the study after 6 month visit. |
| Percentage of Subjects With Reported Adverse Events | 6 months post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Treatment Subjects received a sham treatment in two treatment sessions. | 39 |
| Treatment With DTS-G2 System Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J. | 81 |
| Total | 120 |
Baseline characteristics
| Characteristic | Total | Sham Treatment | Treatment With DTS-G2 System |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 39 Participants | 80 Participants |
| Age Continuous | 32.8 years STANDARD_DEVIATION 10.8 | 34.1 years STANDARD_DEVIATION 11.2 | 32.2 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 120 participants | 39 participants | 81 participants |
| Sex: Female, Male Female | 70 Participants | 26 Participants | 44 Participants |
| Sex: Female, Male Male | 50 Participants | 13 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 39 | 13 / 81 |
| serious Total, serious adverse events | 0 / 39 | 0 / 81 |
Outcome results
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: 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
Time frame: 30 days post-treatment
Population: Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Treatment | Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. | 54 Percentage of Participants |
| Treatment With DTS-G2 System | Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. | 89 Percentage of Participants |
p-value: <0.001ANOVA
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: 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
Time frame: 6 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Treatment | Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. | 44 Percentage of Participants |
| Treatment With DTS-G2 System | Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. | 67 Percentage of Participants |
p-value: 0.019ANOVA
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.
Time frame: 6 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Treatment | Percentage of Subjects With Reported Adverse Events | 13 Percentage of Participants |
| Treatment With DTS-G2 System | Percentage of Subjects With Reported Adverse Events | 28 Percentage of Participants |
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. 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 This outcome is only measured for the treatment group; sham group exited the study after 6 month visit.
Time frame: 12 months
Population: Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With DTS-G2 System | Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit | 69 Percentage of Participants |