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Pilocarpine Microneedles for Sweat Induction (PMN-SI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732195
Recruitment Status : Completed
First Posted : February 1, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Georgia Institute of Technology
Information provided by (Responsible Party):
Lokesh Guglani, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Pilocarpine microneedle patch Device: Pilocarpine Iontophoresis Not Applicable

Detailed Description:

Sweat collection tests are done when a patient is suspected of having cystic fibrosis. This procedure for collection of sweat samples is called the Sweat Test and the measurement of sweat chloride concentration from the collected sweat sample is the gold standard for the diagnosis of Cystic Fibrosis.

When the sweat test is performed for patients in a hospital lab, the standard method uses a small electrical current to push pilocarpine medicine into the skin of the forearm, after which sweat is collected for testing. However, many people do not make enough sweat during this standard method of testing and have to come back for repeated testing. The investigators want to test a new method of putting Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.

The testing will be done once for every participant and no further follow up or additional testing is needed. The study team plans to invite healthy adults who are not taking any medicines to participate through a flyer posted in Emory Children's Center bulletin board. For those interested in participating, the study will be explained to them in detail and an informed consent will be obtained. The subjects will be asked to sit for 45 minutes on a chair as the study related procedures are completed on their arms. The right forearm will be used for pilocarpine iontophoresis method and the left forearm will be used for microneedle-based stimulation method for a period of 5 minutes. An additional microneedle control patch (without any Pilocarpine) will be placed on the left forearm to make sure that there are no skin changes from the microneedles. After the first 5 minutes, the sweat collection devices (Macroduct) will be placed on both forearms to collect sweat samples from each site. After the completion of this 30-minute collection phase, the Macroduct collectors will be removed by the study team and the subject testing will be complete. The study team will store the sweat samples to measure their chloride concentration at the end of the enrollment phase of the study.

This study will be conducted in a research room at Emory Children's Center and no compensation will be provided to the participants. At the end of the study, the research team will compare the two methods based on how much sweat was produced in each individual's arms with either of these methods. The results of this study will help to improve the current technique of sweat testing and help reduce the need for repeated testing in patients being evaluated for Cystic Fibrosis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Compare the Efficacy of Pilocarpine Microneedles With Iontophoresis Method for Sweat Induction in Healthy Human Subjects
Actual Study Start Date : January 20, 2022
Actual Primary Completion Date : March 17, 2022
Actual Study Completion Date : March 25, 2022


Arm Intervention/treatment
Experimental: Pilocarpine microneedle patch
Participants will receive in their left forearm the microneedle patch. Upon application to skin, the MNs penetrate into the skin's upper layers and dissolve in the interstitial fluid to release the loaded drugs. MN patches are painless and can be administered with little or no training.
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.
Other Name: Microneedle patch

Active Comparator: Pilocarpine Iontophoresis
Participants will receive in their right forearm the pilocarpine iontophoresis. Uses a gel disc containing Pilocarpine that drives the medication into the skin with a small electric current (iontophoresis) followed a 30-minute period of sweat collection.
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.




Primary Outcome Measures :
  1. Sweat Volume collected [ Time Frame: 45 min Post-intervention ]
    To compare the sweat volume from application of Pilocarpine Microneedle patch to the forearm of healthy adult subjects with that of standard of care method using pilocarpine iontophoresis


Secondary Outcome Measures :
  1. Sweat Chloride Concentration [ Time Frame: 45 min Post-intervention ]
    Sweat chloride concentrations will be measured from the sweat samples obtained from the application of Pilocarpine Microneedle patch to the forearm of healthy adult subjects and compare them with measurements from standard of care method using pilocarpine iontophoresis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >18 years
  • Signed a written informed consent
  • Not taking any medications
  • No known medical diagnoses or chronic conditions

Exclusion Criteria:

  • Age <18 years
  • Family history of Cystic Fibrosis
  • History of skin disorders (eczema, psoriasis etc.) that could prevent sweat testing on forearms
  • Current medication use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732195


Locations
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United States, Georgia
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Georgia Institute of Technology
Investigators
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Principal Investigator: Lokesh Guglani, MD Emory University
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Responsible Party: Lokesh Guglani, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04732195    
Other Study ID Numbers: IRB00115911
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lokesh Guglani, Emory University:
Sweat test
Microneedle
Pilocarpine
Cystic fibrosis
Iontophoresis
Drug Delivery
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action