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.
COMPLETED
PHASE1
16 participants
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.
2019-11-14
Participant Flow
Participants were healthy volunteers who have their regular dental care at Rhiwbina Dental Surgery.
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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
Treatment Group 2
Treatment Group 3
Treatment Group 4
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place