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

Candesant Biomedical, Inc.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Primary Axillary Hyperhidrosis

Interventions

Roll-In Cohort: Single Application of N-SWEAT PatchDEVICE

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

Randomized Cohort: Single Application of N-SWEAT PatchDEVICE

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

Randomized Cohort: Single Application of Sham PatchDEVICE

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (9)

CA Dermatology & Clinical Research Inst

Encinitas, California, United States

Center for Dermatology Clinical Research

Fremont, California, United States

AE Derm

Rockville, Maryland, United States

Skincare Physicians

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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