Pilocarpine Microneedles for Sweat Induction (PMN-SI)

NCT04732195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-22

Study results available
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Summary

The investigators want to test in this non-randomized clinical trial a new method of administrating Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.

Conditions

Interventions

DEVICE

Pilocarpine microneedle patch

Each microneedle (MN) patch contains an array of solid, water-soluble, micron-scale needles that encapsulate the medication (Pilocarpine). The patch form can be placed directly on the skin.

DEVICE

Pilocarpine Iontophoresis

Pilocarpine Iontophoresis is a process of transdermal pilocarpine delivery by use of a voltage gradient on the skin. An agar gel disc containing pilocarpine is placed under the electrodes which are connected to the Macroduct 3700 Sweat Inducer device.

Sponsors & Collaborators

  • Georgia Institute of Technology

    collaborator OTHER
  • Emory University

    lead OTHER

Principal Investigators

  • Lokesh Guglani, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2022-03-17
Completion
2022-03-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04732195 on ClinicalTrials.gov