Trial Outcomes & Findings for Pilocarpine Microneedles for Sweat Induction (PMN-SI) (NCT NCT04732195)

Last Updated: 2023-05-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

45 min Post-intervention

Results posted on

2023-05-22

Participant Flow

A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.

Unit of analysis: sweat samples

Participant milestones

Participant milestones
Measure	Pilocarpine Microneedle Patch Method Participants received 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 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 Iontophoresis Method Participants received 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. 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.
Overall Study STARTED	50 50	50 50
Overall Study COMPLETED	50 50	50 50
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 45 min Post-intervention

Population: For purposes of this analysis only sweat samples with adequate volume were included from each of the participants.

Outcome measures

Outcome measures
Measure	Pilocarpine Microneedle Patch Method n=44 Participants Participants received 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 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 Iontophoresis Method n=43 Participants Participants received 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. 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.
Amount of Sweat Collected	41.2 mg Standard Deviation 25.0	43.8 mg Standard Deviation 32.3

SECONDARY outcome

Timeframe: 45 min Post-intervention

Population: For purposes of this analysis only sweat samples with adequate volume were included from each of the participants.

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.

Outcome measures

Outcome measures
Measure	Pilocarpine Microneedle Patch Method n=44 Participants Participants received 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 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 Iontophoresis Method n=43 Participants Participants received 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. 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.
Sweat Chloride Concentration	31.2 mmol/L Standard Deviation 13.4	24.0 mmol/L Standard Deviation 13.2

Adverse Events

Pilocarpine Microneedle Patch Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pilocarpine Iontophoresis Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lokesh Guglani

Emory University

Phone: 404-712-2324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pilocarpine Microneedle Patch Method n=50 sweat samples Participants received 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 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 Iontophoresis Method n=50 sweat samples Participants received 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. 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.	Total n=100 sweat samples Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 9.84 • n=5 Participants	35 years STANDARD_DEVIATION 9.84 • n=7 Participants	35 years STANDARD_DEVIATION 9.84 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	34 Participants n=7 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	68 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.
Sex: Female, Male Male	16 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	16 Participants n=7 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	32 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	9 Participants n=7 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	18 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	41 Participants n=7 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	82 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	0 Participants n=7 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.	0 Participants n=5 Participants • A total of 50 subjects provided informed consent for participation in this study. Participants had 2 different types of sweat collection method, one in each arm: the standard of care pilocarpine iontophoresis method on the left forearm and the pilocarpine microneedle patch method on the right forearm. The 50 subjects were able to undergo sweat testing on both forearms during their study visit.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	50 participants n=5 Participants
Sweat collection volume type Adequate sweat collection (>15uL)	44 sweat samples n=50 sweat samples	43 sweat samples n=50 sweat samples	87 sweat samples n=100 sweat samples
Sweat collection volume type Insufficient sweat collection (<15uL)	6 sweat samples n=50 sweat samples	7 sweat samples n=50 sweat samples	13 sweat samples n=100 sweat samples