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

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ClinicalTrials.gov Identifier: NCT04599907
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Candesant Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Device: Roll-In Cohort: Single Application of N-SWEAT Patch Device: Randomized Cohort: Single Application of N-SWEAT Patch Device: Randomized Cohort: Single Application of Sham Patch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: Roll-In Cohort: N-SWEAT Patch - CLOSED
Subjects will be treated with N-SWEAT Patch
Device: Roll-In Cohort: Single Application of 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
Device: Randomized Cohort: Single Application of 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
Device: Randomized Cohort: Single Application of Sham Patch
Single Application of Sham Patch in both axillae for subjects randomized to the control group




Primary Outcome Measures :
  1. Safety of the N-SWEAT Patch [ Time Frame: 2 weeks ]
    Occurrence of AEs and Skin reactions following patch treatment

  2. Improvement in HDSS (Based on a 4-point scale) [ Time Frame: 4 weeks ]
    Achievement of HDSS Score 1 or 2


Secondary Outcome Measures :
  1. QoL (Based on a 5 point scale with 0=no improvement and 5=extreme improvement) [ Time Frame: 4 weeks ]
    Mean improvement in QoL

  2. 50% improvement in GSP (measured in mg/5min) [ Time Frame: 4 weeks ]
    Proportion of treated subjects with at least 50% improvement in GSP from baseline to 4 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599907


Contacts
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Contact: Erin Tims, M.S., CCRP 925.577.6863 etims@candesant.com

Locations
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United States, California
CA Dermatology & Clinical Research Inst Recruiting
Encinitas, California, United States, 92024
Contact: Angie R Inst, RN    760-203-3839    aowens@cdcrinstitute.com   
Contact: Laura Ortega, RN    760-203-3839    lortega@cdcrinstitute.com   
Principal Investigator: Stacy R Smith, MD         
United States, Michigan
Grekin Skin Institute Recruiting
Warren, Michigan, United States, 48088
Contact: Claudia Attala       claudia.attala@adcsclinics.com   
Principal Investigator: Steven Grekin, DO         
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
Contact: Jenjira Skrei       jskrei@associatedskincare.com   
Principal Investigator: Steven Kempers, MD         
United States, North Carolina
Dermatology Consulting Services, Zoe Draelos, MD Recruiting
High Point, North Carolina, United States, 27262
Contact: Crystal Williams       dcs11@northstate.net   
Principal Investigator: Zoe Draelos, MD         
Sponsors and Collaborators
Candesant Biomedical, Inc.
Investigators
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Study Director: Patricia Walker, MD Candesant Biomedical - Medical Monitor
Publications of Results:

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Responsible Party: Candesant Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT04599907    
Other Study ID Numbers: CB-CLP-001
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Candesant Biomedical, Inc.:
Excessive Axillary Sweating
Primary Axillary Hyperhidrosis
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases