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

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

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.

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.

Key Inclusion Criteria:

1. Signed written informed consent
2. At least 22 years old at the time of consent.
3. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
4. GSP >50mg/5min in each axilla
5. Reports a score of HDSS score of 3 or 4

Key Exclusion Criteria:

1. Active skin disease, irritation, or abrasions at either axilla based
2. Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
3. GSP exceeds 300 mg/5min in either axilla