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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roll-In Cohort: N-SWEAT Patch | Experimental | Subjects will be treated with N-SWEAT Patch |
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| Randomized Cohort: N-SWEAT Patch | Experimental | Subjects will be treated with N-SWEAT Patch |
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| Randomized Cohort: Sham Patch | Sham Comparator | Subjects will undergo identical procedure with an inactive sham device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roll-In Cohort: Single Application of N-SWEAT Patch | Device | Single Application of N-SWEAT Patch in both axillae for 10 subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Walker, MD | Candesant Biomedical - Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CA Dermatology & Clinical Research Inst | Encinitas | California | 92024 | United States | ||
| Center for Dermatology Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27744497 | Background | 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. | |
| 22289389 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Roll-In Cohort: N-SWEAT Patch | Subjects will be treated with N-SWEAT Patch Roll-In Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for 10 subjects |
| FG001 | Randomized Cohort: N-SWEAT Patch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2021 | Jun 23, 2023 |
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| 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: Single Application of Sham Patch | Device | Single Application of Sham Patch in both axillae for subjects randomized to the control group |
|
| 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 | 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 | 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 |
| Fremont |
| California |
| 94538 |
| United States |
| AE Derm | Rockville | Maryland | 20850 | United States |
| Skincare Physicians | Boston | Massachusetts | 02467 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Dermatology Consulting Services, Zoe Draelos, MD | High Point | North Carolina | 27262 | United States |
| Research Your Health | Dallas | Texas | 75093 | United States |
| Pariser Derm / Virginia Clinical Research | Norfolk | Virginia | 23502 | United States |
| 29601615 | 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. |
| 25152339 | 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. |
| 15280848 | 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. |
| 22046536 | 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. |
| 15280843 | 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. |
| 29271741 | 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. |
| 18489347 | 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. |
Subjects will be treated with N-SWEAT Patch Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group |
| FG002 | Randomized Cohort: Sham Patch | Subjects will undergo identical procedure with an inactive sham device Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roll-In Cohort: N-SWEAT Patch | Subjects will be treated with N-SWEAT Patch Roll-In Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for 10 subjects |
| BG001 | Randomized Cohort: N-SWEAT Patch | Subjects will be treated with N-SWEAT Patch Randomized Cohort: Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group |
| BG002 | Randomized Cohort: Sham Patch | Subjects will undergo identical procedure with an inactive sham device Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HDSS | Hyperhidrosis Disease Severity Scale (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. This study enrolled those with HDSS 3 or HDSS 4 only. 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 | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of the N-SWEAT Patch | Number of patients with Adverse Events and/or Skin reactions following patch treatment | All subjects treated with the N-SWEAT Patch (roll-in and randomized) were combined into a single population for the safety analysis. | Posted | Count of Participants | Participants | 4 weeks |
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| Primary | 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 | This was conducted on the Efficacy Cohort which included only randomized/blinded subjects. Those treated in the roll-in cohort was not included in the efficacy analyses were aware of the treatment arm to which they were assigned. Additionally, subjects who were found to have been enrolled while taking a conflicting medication were excluded from the efficacy analysis in order to isolate the true device effect. | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | 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) | 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. | The efficacy population was defined in efficacy primary outcome section. It included randomized subjects who were not taking any conflicting medications. | Posted | Mean | 95% Confidence Interval | score on a scale | 4 weeks |
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| Secondary | 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 | 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. | This endpoint defined by the study protocol was for at least 50% of the treated subjects to achieve a reduction in GSP of 50% or more, thus, the sham population was not included in this analysis. Moreover, the GSP measurement (unlike the HDSS or the QoL measurements) required the subjects to report back to the clinic at 4-weeks. Only 43 of the 44 N-SWEAT treated subjects in the efficacy population reported for the 4-week visit. | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | 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 | Posted | Count of Participants | Participants | 4-weeks |
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Adverse Events were collected for 12 weeks, the total duration of the study
Definitions were consistent with clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-SWEAT Patch | Subjects will be treated with N-SWEAT Patch Single Application of N-SWEAT Patch: Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group | 0 | 63 | 0 | 63 | 14 | 63 |
| EG001 | Sham Patch | Subjects will undergo identical procedure with an inactive sham device Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group | 0 | 57 | 0 | 57 | 4 | 57 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device or Treatment Related Events | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Tims, VP of Clinical Affairs | Candesant Biomedical | 19255776863 | etims@candesant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | Jun 23, 2023 | SAP_001.pdf |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| HDSS 4 |
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| Randomized Cohort: Sham Patch |
Subjects will undergo identical procedure with an inactive sham device Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group |
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Subjects will undergo identical procedure with an inactive sham device
Randomized Cohort: Single Application of Sham Patch: Single Application of Sham Patch in both axillae for subjects randomized to the control group
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