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

NCT04599907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-07

Study results available
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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.

Conditions

  • Primary Axillary Hyperhidrosis

Interventions

DEVICE

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

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

DEVICE

Randomized Cohort: Single Application of N-SWEAT Patch

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

DEVICE

Randomized Cohort: Single Application of Sham Patch

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

Sponsors & Collaborators

  • Candesant Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Patricia Walker, MD · Candesant Biomedical - Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2021-07-06
Completion
2021-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599907 on ClinicalTrials.gov