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

Candesant Biomedical

Status: Completed

Conditions: Primary Axillary Hyperhidrosis

Treatments: Device: Randomized Cohort: Single Application of Sham Patch; Device: Roll-In Cohort: Single Application of N-SWEAT Patch; Device: Randomized Cohort: Single Application of N-SWEAT Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT04599907

CB-CLP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Roll-In Cohort: N-SWEAT Patch

Experimental group

Description:

Subjects will be treated with N-SWEAT Patch

Treatment:

Device: Roll-In Cohort: Single Application of N-SWEAT Patch

Randomized Cohort: N-SWEAT Patch

Experimental group

Description:

Subjects will be treated with N-SWEAT Patch

Treatment:

Device: Randomized Cohort: Single Application of N-SWEAT Patch

Randomized Cohort: Sham Patch

Sham Comparator group

Description:

Subjects will undergo identical procedure with an inactive sham device

Treatment:

Device: Randomized Cohort: Single Application of Sham Patch