NCT04732195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 25, 2021

Results QC Date

March 16, 2023

Last Update Submit

April 26, 2023

Conditions

Cystic Fibrosis

Keywords

Sweat testMicroneedlePilocarpineCystic fibrosisIontophoresisDrug Delivery

Outcome Measures

Primary Outcomes (1)

  • Amount of Sweat Collected

    Sweat weight in mg collected after application of Pilocarpine Microneedle patch was compared to the forearm of healthy adult subjects with that of standard of care method using pilocarpine iontophoresis

    45 min Post-intervention

Secondary Outcomes (1)

  • Sweat Chloride Concentration

    45 min Post-intervention

Study Arms (2)

Pilocarpine microneedle patch

EXPERIMENTAL

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

Pilocarpine Iontophoresis

ACTIVE COMPARATOR

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

Interventions

Pilocarpine microneedle patchDEVICE

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.

Also known as: Microneedle patch
Pilocarpine microneedle patch
Pilocarpine IontophoresisDEVICE

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.

Pilocarpine Iontophoresis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta - Egleston Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Chen JY, Li S, Silva GL, Chandler JD, Prausnitz MR, Guglani L. Sweat induction using Pilocarpine microneedle patches for sweat testing in healthy adults. J Cyst Fibros. 2024 Jan;23(1):112-119. doi: 10.1016/j.jcf.2023.04.014. Epub 2023 May 25.

    PMID: 37236899DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Results Point of Contact

Title
Dr. Lokesh Guglani
Organization
Emory University
lokesh.guglani@emory.edu
404-712-2324

Study Officials

  • Lokesh Guglani, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 1, 2021

Study Start

January 20, 2022

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

May 22, 2023

Results First Posted

May 22, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)