Trial Outcomes & Findings for A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity (NCT NCT03629041)

NCT ID: NCT03629041

Last Updated: 2019-11-14

Results Overview

Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Results posted on

2019-11-14

Participant Flow

Participants were healthy volunteers who have their regular dental care at Rhiwbina Dental Surgery.

Participant milestones

Participant milestones
Measure
Treatment Group 1
At visit 1 the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days after visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 2
At visit 1 the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days from visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 3
At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days from visit 1) the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 4
At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days after visit 1) the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Visit 1
STARTED
4
4
4
4
Visit 1
COMPLETED
4
4
4
4
Visit 1
NOT COMPLETED
0
0
0
0
Visit 2 (2 Weeks ± 3 Days From Visit 1)
STARTED
4
4
4
4
Visit 2 (2 Weeks ± 3 Days From Visit 1)
COMPLETED
4
3
4
4
Visit 2 (2 Weeks ± 3 Days From Visit 1)
NOT COMPLETED
0
1
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment Group 1
At visit 1 the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days after visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 2
At visit 1 the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days from visit 1) the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 3
At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days from visit 1) the left upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes and the right upper palatal area was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Treatment Group 4
At visit 1 the left upper anterior buccal sulcus was treated with lidocaine on a patch with no microneedles for three minutes and the right upper anterior buccal sulcus was treated with lidocaine on a microneedle patch for three minutes. Tests 1, 2 and 3 were then performed on both sites. At visit 2 (2 weeks +/- 3 days after visit 1) the left upper palatal area was treated with lidocaine on a microneedle patch for three minutes and the right upper palatal area was treated with lidocaine on a patch with no microneedles for three minutes. Tests 1, 2 and 3 were then performed on both sites.
Visit 2 (2 Weeks ± 3 Days From Visit 1)
Withdrawal by Subject
0
1
0
0

Baseline Characteristics

A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=16 Participants
All study participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
31.4 years
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United Kingdom
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.

Outcome measures

Outcome measures
Measure
Treatment A - Microneedle Patch, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment A - Microneedle Patch, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
VAS scores, test 1
5.1 units on a scale
Standard Deviation 5.8
12.3 units on a scale
Standard Deviation 11.6
0.7 units on a scale
Standard Deviation 1.0
4.0 units on a scale
Standard Deviation 5.8
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
VAS scores, test 2
11.9 units on a scale
Standard Deviation 11.3
18.7 units on a scale
Standard Deviation 12.4
2.8 units on a scale
Standard Deviation 4.0
6.9 units on a scale
Standard Deviation 6.6
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
VAS scores, test 3
26.8 units on a scale
Standard Deviation 20.1
39.5 units on a scale
Standard Deviation 25.1
18.3 units on a scale
Standard Deviation 17.5
30.6 units on a scale
Standard Deviation 20.7

PRIMARY outcome

Timeframe: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Pain levels will be recorded using a Verbal Pain Grading. For the verbal pain grading, subjects are asked to score either zero, mild, moderate or severe. In test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site.

Outcome measures

Outcome measures
Measure
Treatment A - Microneedle Patch, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment A - Microneedle Patch, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Verbal Pain Grading, Test 1- Zero
8 Participants
5 Participants
15 Participants
13 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Verbal Pain Grading, Test 1 - Mild
8 Participants
8 Participants
0 Participants
2 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Verbal Pain Grading, Test 1 - Moderate
0 Participants
3 Participants
0 Participants
0 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Verbal Pain Grading, Test 1 - Severe
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 2, the same needle as test 1 was inserted through the oral mucosa and down to contact bone.

Outcome measures

Outcome measures
Measure
Treatment A - Microneedle Patch, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment A - Microneedle Patch, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Verbal Pain Grading, Test 2 - Severe
0 Participants
0 Participants
0 Participants
0 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Verbal Pain Grading, Test 2 - Zero
8 Participants
3 Participants
14 Participants
11 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Verbal Pain Grading, Test 2 - Mild
5 Participants
9 Participants
1 Participants
4 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Verbal Pain Grading, Test 2 - Moderate
3 Participants
4 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.

Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 3, the same needle as test 1 and test 2 was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.

Outcome measures

Outcome measures
Measure
Treatment A - Microneedle Patch, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Palatal
n=16 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment A - Microneedle Patch, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Buccal
n=15 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Verbal Pain Grading, Test 3 - Zero
1 Participants
1 Participants
3 Participants
1 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Verbal Pain Grading, Test 3 - Mild
7 Participants
3 Participants
8 Participants
7 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Verbal Pain Grading, Test 3 - Moderate
8 Participants
10 Participants
4 Participants
7 Participants
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Verbal Pain Grading, Test 3 - Severe
0 Participants
2 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Events were collected from the time of informed consent until end of treatment or when an ongoing AE had resolved whichever was latest, unless the PI & the Innoture contact from the clinical investigation plan agreed that no further follow up was needed.

Adverse events were recorded

Outcome measures

Outcome measures
Measure
Treatment A - Microneedle Patch, Palatal
n=4 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Palatal
n=4 Participants
The application of a 5% topical lidocaine gel to the palatal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the palatal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the palatal mucosa within the participants mouth.
Treatment A - Microneedle Patch, Buccal
n=4 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa within the participants mouth using a microneedle patch. The microneedle patch was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Treatment B - Patch With no Microneedles, Buccal
n=4 Participants
The application of a 5% topical lidocaine gel to the buccal mucosa sites within the participants mouth using a patch with no microneedles. The patch with no microneedles was applied to the buccal mucosa for 3 minutes, followed by infiltration with local anaesthetic to the buccal mucosa within the participants mouth.
Adverse Events in Healthy Participants When a Proprietary Topical 5% Lidocaine Dental Gel Was Applied to the Oral Mucosa With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
0 Events
0 Events
0 Events
0 Events

Adverse Events

Treatment Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Group 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Group 4

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

Jemma Burridge, Clinical Project Manager

Innoture Ltd

Phone: +44 (0)7799 902476

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place