Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

Study Overview
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Brief Summary
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The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Detailed Description
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The Sahara Study is intended to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis. Safety of the N-SWEAT Patch will be confirmed by assessing the occurrence of local skin reactions, treatment-related adverse events (AEs) and Serious Adverse Events (SAEs). Demonstration of effectiveness will be assessed by a significant improvement (reduction) in Hyperhidrosis Disease Severity Score (HDSS) in subjects treated with the N-SWEAT Patch. Secondary and additional endpoints based on complementary clinical instruments, including Quality of Life Measures (QOL) and Gravimetric Sweat Production GSP), have been included to further demonstrate performance.

Official Title
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An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Device: Roll-In Cohort: Single Application of N-SWEAT Patch
* Device: Randomized Cohort: Single Application of N-SWEAT Patch
* Device: Randomized Cohort: Single Application of Sham Patch


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Signed written informed consent At least 22 years old at the time of consent. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health GSP >50mg/5min in each axilla Reports a score of HDSS score of 3 or 4 Key Exclusion Criteria: Active skin disease, irritation, or abrasions at either axilla based Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis GSP exceeds 300 mg/5min in either axilla

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roll-In Cohort: N-SWEAT Patch<br>Subjects will be treated with N-SWEAT Patch | Device: Roll-In Cohort: Single Application of N-SWEAT Patch<br>* Single Application of N-SWEAT Patch in both axillae for 10 subjects<br>|
| Experimental: Randomized Cohort: N-SWEAT Patch<br>Subjects will be treated with N-SWEAT Patch | Device: Randomized Cohort: Single Application of N-SWEAT Patch<br>* Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group<br>|
| Sham Comparator: Randomized Cohort: Sham Patch<br>Subjects will undergo identical procedure with an inactive sham device | Device: Randomized Cohort: Single Application of Sham Patch<br>* Single Application of Sham Patch in both axillae for subjects randomized to the control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the N-SWEAT Patch | Number of patients with Adverse Events and/or Skin reactions following patch treatment | 4 weeks | 
| Effectiveness of the N-SWEAT Patch to Change Subjects From an HDSS 3 or 4 at Baseline to HDSS 1 or 2 at 4 Weeks | Achievement of Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at 4 weeks. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and and always interferes with my daily activities | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in the Quality of Life. Assessed by Evaluating How Much Sweat Bothers or Impacts the Daily Life of Patients (a Higher Score Means More Bother and More Impact) | Two Quality of Life (QoL) Assessments were conducted as part of this endpoint. The Level of Bother: Subjects were asked how much their sweat bothered them on a Scale of 1 (not at all bothered by sweating) to 5 (extremely bothered by sweating). The Impact of Sweat on Daily Activities: Subjects were asked how much their sweating impacts their daily activities on a scale of 1 (not at all impacted) to 5 (extremely impacted). The mean improvement of each of these was calculated by comparing the mean baseline level to the mean level at 4 weeks. The mean change in the level of improvement was analyzed for significance. A larger decrease in these levels, i.e. less bother and less impact, (indicated by a larger negative number) will show the most improvement in QoL. | 4 weeks | 
| Percentage of Patients With a Mean Change in Gravimetric Sweat Production (GSP) Indicating That Sweating After Treatment is Cut in Half From Pre-treatment Sweat | Gravimetric Sweat Production (GSP) measures the amount of sweat that is produced in a 5-minute period. The percentage of treated subjects with at least a 50% reduction in mean GSP (mean of both axilla) from baseline to 4 weeks was analyzed for this endpoint. | 4 weeks | 
| Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | Patients with a 2-point decrease in HDSS indicate improvement in sweating. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and always interferes with my daily activities | 4-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive Axillary Sweating, Primary Axillary Hyperhidrosis