CompletedNot Applicable

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

United States120 participantsStarted 2020-10-13

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent
✓. At least 22 years old at the time of consent.
✓. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
✓. GSP \>50mg/5min in each axilla
✓. Reports a score of HDSS score of 3 or 4

Exclusion criteria

✕. Active skin disease, irritation, or abrasions at either axilla based
✕. Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
✕. GSP exceeds 300 mg/5min in either axilla

What they're measuring

Safety of the N-SWEAT Patch

Timeframe: 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

Timeframe: 4 weeks

Trial details

NCT IDNCT04599907

SponsorCandesant Biomedical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-06

Results submitted2023-06-23

View on ClinicalTrials.gov More Primary Axillary Hyperhidrosis trials