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Roll-In Cohort: Single Application of N-SWEAT Patch for Excessive sweating

N/A
Waitlist Available
Research Sponsored by Candesant Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

This trial is testing a special patch called the N-SWEAT Patch to help people who sweat too much under their arms. The patch is placed on the skin and works by reducing the amount of sweat produced. The study will check if the patch is safe and if it effectively reduces sweating.

Eligible Conditions
  • Excessive sweating

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Safety of the N-SWEAT Patch
Secondary study objectives
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)
Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Roll-In Cohort: N-SWEAT PatchExperimental Treatment1 Intervention
Subjects will be treated with N-SWEAT Patch
Group II: Randomized Cohort: N-SWEAT PatchExperimental Treatment1 Intervention
Subjects will be treated with N-SWEAT Patch
Group III: Randomized Cohort: Sham PatchPlacebo Group1 Intervention
Subjects will undergo identical procedure with an inactive sham device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roll-In Cohort: Single Application of N-SWEAT Patch
2020
N/A
~120
Randomized Cohort: Single Application of N-SWEAT Patch
2020
N/A
~120

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Who is running the clinical trial?

Candesant Biomedical, Inc.Lead Sponsor
Patricia Walker, MDStudy DirectorCandesant Biomedical - Medical Monitor
1 Previous Clinical Trials
1 Total Patients Enrolled
~24 spots leftby Dec 2025
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