Clinical trial NCT04599907: Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
Official title: An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive Axillary Sweating
Primary Axillary Hyperhidrosis
Lead sponsor: Candesant Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Key Inclusion Criteria:

1. Signed written informed consent
2. At least 22 years old at the time of consent.
3. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
4. GSP \>50mg/5min in each axilla
5. Reports a score of HDSS score of 3 or 4

Key Exclusion Criteria:

1. Active skin disease, irritation, or abrasions at either axilla based
2. Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
3. GSP exceeds 300 mg/5min in either axilla

Primary outcomes:
measure: Safety of the N-SWEAT Patch
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: 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)
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: CA Dermatology & Clinical Research Inst
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Rockville
country: United States
facility: AE Derm
state: Maryland
city: Boston
country: United States
facility: Skincare Physicians
state: Massachusetts
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: High Point
country: United States
facility: Dermatology Consulting Services, Zoe Draelos, MD
state: North Carolina
city: Dallas
country: United States
facility: Research Your Health
state: Texas
city: Norfolk
country: United States
facility: Pariser Derm / Virginia Clinical Research
state: Virginia
Study officials:
affiliation: Candesant Biomedical - Medical Monitor
name: Patricia Walker, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.