Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

NCT04599907 | Completed Results DMC FDA Device

• 1 other identifier: CB-CLP-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

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.

Conditions

Primary Axillary Hyperhidrosis

Keywords

Excessive Axillary Sweating; Primary Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• Safety of the N-SWEAT Patch

  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

  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 Outcomes (3)

• 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)

  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

  4 weeks

• Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment

  4-weeks

Study Arms (3)

Roll-In Cohort: N-SWEAT Patch

EXPERIMENTAL

Subjects will be treated with N-SWEAT Patch

Device: Roll-In Cohort: Single Application of N-SWEAT Patch

Randomized Cohort: N-SWEAT Patch

EXPERIMENTAL

Subjects will be treated with N-SWEAT Patch

Device: Randomized Cohort: Single Application of N-SWEAT Patch

Randomized Cohort: Sham Patch

SHAM COMPARATOR

Subjects will undergo identical procedure with an inactive sham device

Device: Randomized Cohort: Single Application of Sham Patch

Interventions

Roll-In Cohort: Single Application of N-SWEAT Patch DEVICE

Single Application of N-SWEAT Patch in both axillae for 10 subjects

Roll-In Cohort: N-SWEAT Patch

Randomized Cohort: Single Application of N-SWEAT Patch DEVICE

Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group

Randomized Cohort: N-SWEAT Patch

Randomized Cohort: Single Application of Sham Patch DEVICE

Single Application of Sham Patch in both axillae for subjects randomized to the control group

Randomized Cohort: Sham Patch

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Candesant Biomedical, Inc.: lead

Study Sites (9)

CA Dermatology & Clinical Research Inst

Encinitas, California, 92024, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

AE Derm

Rockville, Maryland, 20850, United States

Location

Skincare Physicians

Boston, Massachusetts, 02467, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Dermatology Consulting Services, Zoe Draelos, MD

High Point, North Carolina, 27262, United States

Location

Research Your Health

Dallas, Texas, 75093, United States

Location

Pariser Derm / Virginia Clinical Research

Norfolk, Virginia, 23502, United States

Location

Related Publications (9)

• 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.

  PMID: 27744497 BACKGROUND

• 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.

  PMID: 22289389 BACKGROUND

• 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.

  PMID: 29601615 BACKGROUND

• 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.

  PMID: 25152339 BACKGROUND

• 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.

  PMID: 15280848 BACKGROUND

• 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.

  PMID: 22046536 BACKGROUND

• 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.

  PMID: 15280843 BACKGROUND

• 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.

  PMID: 29271741 BACKGROUND

• 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.

  PMID: 18489347 BACKGROUND

Results Point of Contact

• Title: Erin Tims, VP of Clinical Affairs
• Organization: Candesant Biomedical

etims@candesant.com

19255776863

Study Officials

• Patricia Walker, MD

  Candesant Biomedical - Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 23, 2020
• Study Start: October 13, 2020
• Primary Completion: July 6, 2021
• Study Completion: December 20, 2021
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)