- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599907
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Encinitas, California, United States, 92024
- CA Dermatology & Clinical Research Inst
-
Fremont, California, United States, 94538
- Center for Dermatology Clinical Research
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- AE Derm
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02467
- SkinCare Physicians
-
-
Michigan
-
Warren, Michigan, United States, 48088
- Grekin Skin Institute
-
-
Minnesota
-
Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services, Zoe Draelos, MD
-
-
Texas
-
Dallas, Texas, United States, 75093
- Research Your Health
-
-
Virginia
-
Norfolk, Virginia, United States, 23502
- Pariser Derm / Virginia Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Roll-In Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
|
Single Application of N-SWEAT Patch in both axillae for 10 subjects
|
Experimental: Randomized Cohort: N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
|
Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
|
Sham Comparator: Randomized Cohort: Sham Patch
Subjects will undergo identical procedure with an inactive sham device
|
Single Application of Sham Patch in both axillae for subjects randomized to the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the N-SWEAT Patch
Time Frame: 4 weeks
|
Number of patients with Adverse Events and/or Skin reactions following patch treatment
|
4 weeks
|
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
Time Frame: 4 weeks
|
Achievement of Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at 4 weeks. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and and always interferes with my daily activities |
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 4 weeks
|
Two Quality of Life (QoL) Assessments were conducted as part of this endpoint. The Level of Bother: Subjects were asked how much their sweat bothered them on a Scale of 1 (not at all bothered by sweating) to 5 (extremely bothered by sweating). The Impact of Sweat on Daily Activities: Subjects were asked how much their sweating impacts their daily activities on a scale of 1 (not at all impacted) to 5 (extremely impacted). The mean improvement of each of these was calculated by comparing the mean baseline level to the mean level at 4 weeks. The mean change in the level of improvement was analyzed for significance. A larger decrease in these levels, i.e. less bother and less impact, (indicated by a larger negative number) will show the most improvement in QoL. |
4 weeks
|
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
Time Frame: 4 weeks
|
Gravimetric Sweat Production (GSP) measures the amount of sweat that is produced in a 5-minute period.
The percentage of treated subjects with at least a 50% reduction in mean GSP (mean of both axilla) from baseline to 4 weeks was analyzed for this endpoint.
|
4 weeks
|
Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
Time Frame: 4-weeks
|
Patients with a 2-point decrease in HDSS indicate improvement in sweating. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and always interferes with my daily activities |
4-weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Patricia Walker, MD, Candesant Biomedical - Medical Monitor
Publications and helpful links
General Publications
- Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
- Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016 Dec;308(10):743-749. doi: 10.1007/s00403-016-1697-9. Epub 2016 Oct 15.
- Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.
- Glaser DA, Coleman WP 3rd, Fan LK, Kaminer MS, Kilmer SL, Nossa R, Smith SR, O'Shaughnessy KF. A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Dermatol Surg. 2012 Feb;38(2):185-91. doi: 10.1111/j.1524-4725.2011.02250.x. Epub 2012 Jan 30.
- Glaser DA, Hebert A, Pieretti L, Pariser D. Understanding Patient Experience With Hyperhidrosis: A National Survey of 1,985 Patients. J Drugs Dermatol. 2018 Apr 1;17(4):392-396.
- Hamm H. Impact of hyperhidrosis on quality of life and its assessment. Dermatol Clin. 2014 Oct;32(4):467-76. doi: 10.1016/j.det.2014.06.004. Epub 2014 Jul 16.
- Stander M, Wallis LA. The emergency management and treatment of severe burns. Emerg Med Int. 2011;2011:161375. doi: 10.1155/2011/161375. Epub 2011 Sep 4.
- Wade R, Rice S, Llewellyn A, Moloney E, Jones-Diette J, Stoniute J, Wright K, Layton AM, Levell NJ, Stansby G, Craig D, Woolacott N. Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis. Health Technol Assess. 2017 Dec;21(80):1-280. doi: 10.3310/hta21800.
- Wilke K, Martin A, Terstegen L, Biel SS. A short history of sweat gland biology. Int J Cosmet Sci. 2007 Jun;29(3):169-79. doi: 10.1111/j.1467-2494.2007.00387.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB-CLP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Axillary Hyperhidrosis
-
Dr. August Wolff GmbH & Co. KG ArzneimittelTherapeutics, Inc.Not yet recruiting
-
Ulthera, IncCompleted
-
Botanix PharmaceuticalsCompletedPrimary Axillary HyperhidrosisUnited States
-
Dr. August Wolff GmbH & Co. KG ArzneimittelFGK Clinical Research GmbH; Nuvisan GmbH; Charles River Biopharmaceutical Services...CompletedPrimary Axillary HyperhidrosisGermany
-
Ulthera, IncTerminatedPrimary Axillary HyperhidrosisUnited States
-
Mae Fah Luang University HospitalCompletedPrimary Axillary Hyperhidrosis
-
Dr. August Wolff GmbH & Co. KG ArzneimittelRecruitingPrimary Axillary HyperhidrosisGermany
-
Dr. August Wolff GmbH & Co. KG ArzneimittelCompletedPrimary Axillary HyperhidrosisGermany
-
Botanix PharmaceuticalsCompletedPrimary Axillary HyperhidrosisUnited States
-
Xijing HospitalCompletedPrimary Axillary HyperhidrosisChina
Clinical Trials on Roll-In Cohort: Single Application of N-SWEAT Patch
-
Northwestern UniversityCompleted
-
GenmabBioNTech SEActive, not recruitingCervical Cancer | Squamous Cell Carcinoma of the Head and Neck | Triple Negative Breast Cancer | Non-small Cell Lung Cancer | Solid Tumors | Endometrial Carcinoma | Urothelial CarcinomaUnited States, Spain, Israel, Czechia, Georgia, Italy, Poland, Turkey, Hungary, Ukraine
-
Fundação de Medicina Tropical Dr. Heitor Vieira...Completed
-
Gilead SciencesCompletedHepatitis CUnited States, Puerto Rico
-
PfizerCompleted