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Roll-In Cohort: Single Application of N-SWEAT Patch for Excessive Underarm 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
Awards & highlights
Study Summary
This study is evaluating whether a patch may help reduce sweating in the underarm area.
Eligible Conditions
- Excessive Underarm Sweating
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Michigan
North Carolina
How old are they?
18 - 65
What site did they apply to?
Grekin Skin Institute
Dermatology Consulting Services, Zoe Draelos, MD
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
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