Primary Axillary Hyperhidrosis
Conditions
Keywords
Excessive Axillary Sweating, Primary Axillary Hyperhidrosis
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.
Interventions
DEVICERoll-In Cohort: Single Application of N-SWEAT Patch
Single Application of N-SWEAT Patch in both axillae for 10 subjects
DEVICERandomized Cohort: Single Application of N-SWEAT Patch
Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
DEVICERandomized Cohort: Single Application of Sham Patch
Single Application of Sham Patch in both axillae for subjects randomized to the control group
Sponsors
Candesant Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the N-SWEAT Patch | 4 weeks | Number of patients with Adverse Events and/or Skin reactions following patch treatment |
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | 4-weeks | 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 |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 53 |
| 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 | 57 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 7 | 6 |
Baseline characteristics
| Characteristic | Randomized Cohort: N-SWEAT Patch | Randomized Cohort: Sham Patch | Roll-In Cohort: N-SWEAT Patch | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 57 Participants | 10 Participants | 120 Participants |
| Age, Continuous | 32.6 years STANDARD_DEVIATION 7.3 | 34.4 years STANDARD_DEVIATION 8.4 | 40.9 years STANDARD_DEVIATION 15.3 | 34.3 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 1 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | 9 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HDSS HDSS 3 | 21 Participants | 25 Participants | 4 Participants | 50 Participants |
| HDSS HDSS 4 | 32 Participants | 32 Participants | 6 Participants | 70 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 5 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 13 Participants | 0 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 37 Participants | 9 Participants | 77 Participants |
| Region of Enrollment United States | 53 participants | 57 participants | 10 participants | 120 participants |
| Sex: Female, Male Female | 30 Participants | 36 Participants | 7 Participants | 73 Participants |
| Sex: Female, Male Male | 23 Participants | 21 Participants | 3 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 57 |
| other Total, other adverse events | 14 / 63 | 4 / 57 |
| serious Total, serious adverse events | 0 / 63 | 0 / 57 |
Outcome results
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
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-SWEAT Patch Treated | 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 Participants |
| 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 | 19 Participants |
p-value: <0.05Cochran-Mantel-Haenszel
Primary
Safety of the N-SWEAT Patch
Number of patients with Adverse Events and/or Skin reactions following patch treatment
Time frame: 4 weeks
Population: All subjects treated with the N-SWEAT Patch (roll-in and randomized) were combined into a single population for the safety analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-SWEAT Patch Treated | Safety of the N-SWEAT Patch | 14 Participants |
| Randomized Cohort: Sham Patch | Safety of the N-SWEAT Patch | 4 Participants |
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.
Time frame: 4 weeks
Population: The efficacy population was defined in efficacy primary outcome section. It included randomized subjects who were not taking any conflicting medications.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| N-SWEAT Patch Treated | 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) | Change in the Level of Bother due to Sweat | -1.52 score on a scale |
| N-SWEAT Patch Treated | 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) | Change in Level of Impact of Sweat on Daily Activities | -1.44 score on a scale |
| Randomized Cohort: Sham Patch | 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) | Change in the Level of Bother due to Sweat | -0.61 score on a scale |
| Randomized Cohort: Sham Patch | 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) | Change in Level of Impact of Sweat on Daily Activities | -0.57 score on a scale |
Comparison: This is the data for the Level of Botherstatistical analysisp-value: <0.0595% CI: [-1.42, -0.04]Mixed Models Analysis
Comparison: This is the data for the Level of Impact on Daily Activities Statistical Analysisp-value: <0.0595% CI: [-1.35, -0.4]Mixed Models Analysis
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
Time frame: 4-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-SWEAT Patch Treated | Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | 19 Participants |
| Randomized Cohort: Sham Patch | Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment | 7 Participants |
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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 Participants |