N/A
N=120
Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
Primary Axillary Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT04599907 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Safety of the N-SWEAT Patch — 14; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Candesant Biomedical, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the N-SWEAT Patch |
14; 4 | — |
| PRIMARY 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 |
28; 19 | <0.05 sig |
| SECONDARY 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) |
-1.52; -0.61; -1.44; -0.57 | <0.05 sig |
| SECONDARY 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 |
26 | — |
| SECONDARY Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment |
19; 7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04599907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.