Trials / Completed
CompletedNCT04599907
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Candesant Biomedical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Roll-In Cohort: Single Application of N-SWEAT Patch | Single Application of N-SWEAT Patch in both axillae for 10 subjects |
| DEVICE | Randomized Cohort: Single Application of N-SWEAT Patch | Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group |
| DEVICE | Randomized Cohort: Single Application of Sham Patch | Single Application of Sham Patch in both axillae for subjects randomized to the control group |
Timeline
- Start date
- 2020-10-13
- Primary completion
- 2021-07-06
- Completion
- 2021-12-20
- First posted
- 2020-10-23
- Last updated
- 2023-09-07
- Results posted
- 2023-09-07
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04599907. Inclusion in this directory is not an endorsement.