An interventional study of Roll-In Cohort: Single Application of N-SWEAT Patch and Randomized Cohort: Single Application of N-SWEAT Patch in Primary Axillary Hyperhidrosis, sponsored by Candesant Biomedical, Inc.. Completed at 9 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Candesant Biomedical, Inc. · Not applicable, Interventional, and Treatment
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.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →This is the only study on the registry with Candesant Biomedical, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated with N-SWEAT Patch
Device: Roll-In Cohort: Single Application of N-SWEAT Patch
Subjects will be treated with N-SWEAT Patch
Device: Randomized Cohort: Single Application of N-SWEAT Patch
Subjects will undergo identical procedure with an inactive sham device
Device: Randomized Cohort: Single Application of Sham Patch
Single Application of N-SWEAT Patch in both axillae for 10 subjects
Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
Single Application of Sham Patch in both axillae for subjects randomized to the control group
Safety of the N-SWEAT Patch
Number of patients with Adverse Events and/or Skin reactions following patch treatment
Time frame: 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
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 4-weeks
| Milestone | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch |
|---|---|---|---|
| Started | 10 | 53 | 57 |
| Completed | 9 | 45 | 51 |
| Not completed | 1 | 8 | 6 |
| Withdrew: Withdrawal by subject | 1 | 7 | 6 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
Number of patients with Adverse Events and/or Skin reactions following patch treatment
| Participants | N-SWEAT Patch Treated | Randomized Cohort: Sham Patch |
|---|---|---|
| Safety of the N-SWEAT Patch | 14 | 4 |
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
| Participants | Randomized Cohort: N-SWEAT Patch Treated | Randomized Cohort: Sham Patch |
|---|---|---|
| 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 | 28 | 19 |
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.
| score on a scale | Randomized Cohort: N-SWEAT Patch Treated | Randomized Cohort: Sham Patch |
|---|---|---|
| Change in the Level of Bother due to Sweat | -1.52 (-1.88 to -1.16) | -0.61 (-0.98 to -0.25) |
| Change in Level of Impact of Sweat on Daily Activities | -1.44 (-1.77 to -1.10) | -0.57 (-0.91 to -0.23) |
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.
| Participants | Randomized Cohort: N-SWEAT Patch Treated |
|---|---|
| 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 | 26 |
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
| Participants | Randomized Cohort: N-SWEAT Patch Treated | Randomized Cohort: Sham Patch |
|---|---|---|
| Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | 19 | 7 |
Collected over Adverse Events were collected for 12 weeks, the total duration of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N-SWEAT Patch | 0/63 (0%) | 0/63 (0%) | 14/63 (22.2%) |
| Sham Patch | 0/57 (0%) | 0/57 (0%) | 4/57 (7%) |
| Event | N-SWEAT Patch | Sham Patch |
|---|---|---|
| Device or Treatment Related EventsInjury, poisoning and procedural complications | 14/63 | 4/57 |
| Age, Categorical(Participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 53 | 57 | 120 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| Mean | 40.9 ± 15.3 | 32.6 ± 7.3 | 34.4 ± 8.4 | 34.3 ± 9.4 |
| Sex: Female, Male(Participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| Female | 7 | 30 | 36 | 73 |
| Male | 3 | 23 | 21 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 5 | 9 | 15 |
| Not Hispanic or Latino | 9 | 48 | 48 | 105 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 2 | 3 |
| Asian | 1 | 8 | 5 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 0 | 12 | 13 | 25 |
| White | 9 | 31 | 37 | 77 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| United States | 10 | 53 | 57 | 120 |
| HDSS(Participants) | Roll-In Cohort: N-SWEAT Patch | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Total |
|---|---|---|---|---|
| HDSS 3 | 4 | 21 | 25 | 50 |
| HDSS 4 | 6 | 32 | 32 | 70 |
PDFs hosted by the registry, ClinicalTrials.gov.
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