Underarm sweat
Conditions
Interventions
None listed
Sponsors
miraDry, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria. Candidates for this study must meet ALL of the following criteria: a) Adults (aged >=18 years) at time of consent. b) A HDSS score of 3 or 4. c) Excess sweating evidenced by at least two of the following: a. Impairs daily activities b. Frequency of at least one episode per week c. Age of onset less than 25 years old d. Positive family history e. Cessation of focal sweating during sleep d) In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated. e) Willing and able to comply with protocol requirements and all study visits. f) Female patients of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria. Candidates will be excluded if ANY of the following conditions apply: a) A cardiac pacemaker or cardiac defibrillator or other electronic implant. b) Requires supplemental oxygen. c) Known resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine. d) Secondary excess sweating due to medications, infections, malignancy. e) Evidence of active infection. f) Prior liposuction or other dissection surgery for axillary excess sweating. g) Oral anticholinergic medication use (e.g., Glycopyrrolate) or cholinomimetic medication use within the last 4 weeks or planned use during the study*s follow-up phase. h) Botulinum treatment of the axilla within the last 12 months. i) Currently participating in or recently participated in another clinical trial (within the last 30 days). j) History of or current neurologic deficit in the treatment area and/or limb. k) History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) a history of successfully treated cancer that have been disease-free for five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety: Incidence of device and/or treatment related Serious Adverse Events (SAEs) through 30 days. • Efficacy: Responder rate at 30 days, where a responder is defined as a study participant that reports a Hyperhidrosis Severity Scale (HDSS) score of 1 or 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of device and/or treatment related SAEs through 6 months. • Incidence of device and/or treatment related AEs through 6 months. • Responder rate at 3 months and 6 months, where a responder is defined as a study participant that reports a HDSS score of 1 or 2. • Change in quality of life (QoL) from baseline to 30 days, 3 months, and 6 months, as measured by the Dermatology Life Quality Index (DLQI). • Change in odor assessment score from baseline to 30 days, 3 months, and 6 months. • Satisfaction with reduction in odor at 30 days, 3 months, and 6 months. • Reduction in axillary hair at 30 days, 3 months, and 6 months. • Satisfaction with reduction in axillary hair at 30 days, 3 months, and 6 months. | — |
Countries
Netherlands
Outcome results
None listed