Cystic FibrosisNCT04732195
Pilocarpine Microneedles for Sweat Induction (PMN-SI)
A study testing Pilocarpine microneedle patch and Pilocarpine Iontophoresis in people with Cystic Fibrosis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Pilocarpine microneedle patch and Pilocarpine Iontophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 17 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Signed a written informed consent
- Not taking any medications
- No known medical diagnoses or chronic conditions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 30322
About this study
Official title: A Pilot Study to Compare the Efficacy of Pilocarpine Microneedles With Iontophoresis Method for Sweat Induction in Healthy Human Subjects
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Pilocarpine microneedle patch, Pilocarpine Iontophoresis
- Keywords
- Sweat test, Microneedle, Pilocarpine, Cystic fibrosis, Iontophoresis, Drug Delivery
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine microneedle patchDevice
Also called 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pilocarpine Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 min Post-intervention
Secondary outcomes (1)
Sweat Chloride Concentration
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.
Measured: 45 min Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start20 Jan 2022
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Principal investigator, Lokesh Guglani, Emory University
- Investigators
- Lokesh Guglani, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732195
- Sponsor's protocol ID
- IRB00115911
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2021
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37236899
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare the Efficacy of Pilocarpine Microneedles With Iontophoresis Method for Sweat Induction in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT04732195
- Acronym / sponsor ID
- IRB00115911
- Conditions
- Cystic Fibrosis
- Keywords
- Sweat test, Microneedle, Pilocarpine, Cystic fibrosis, Iontophoresis, Drug Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 22 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine microneedle patch | Experimental | Device: Pilocarpine microneedle patchParticipants 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. |
| Pilocarpine Iontophoresis | Active comparator | Device: Pilocarpine IontophoresisParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Signed a written informed consent
- Not taking any medications
- No known medical diagnoses or chronic conditions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilocarpine microneedle patchAlso: Microneedle patchEach 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 microneedle patch |
| Pilocarpine IontophoresisPilocarpine 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. | Device | Pilocarpine Iontophoresis |
Primary outcome
Amount of Sweat Collected
Time frame: 45 min Post-intervention
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
1 secondary outcome
Sweat Chloride Concentration
Time frame: 45 min Post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37236899Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lokesh Guglani, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilocarpine microneedle patch and Pilocarpine Iontophoresis in people with Cystic Fibrosis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Sweat Collected (time frame: 45 min Post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04732195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.