Trial Outcomes & Findings for The Effect of Microneedle Pretreatment on Topical Anesthesia (NCT NCT02596750)
NCT ID: NCT02596750
Last Updated: 2018-11-27
Results Overview
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
COMPLETED
NA
21 participants
2 min
2018-11-27
Participant Flow
Measure Analysis Population Description: This study incorporated a split body design. 21 participants were studied, each participant had a different treatment on each of their forearms, 42 forearms or data points overall.
Unit of analysis: Forearm
Participant milestones
| Measure |
Microneedle Treatment
Microneedle treatments consisted of pre-treatment with 200 micrometer microneedle rollers and then application of topical 4% lidocaine.
|
Sham Microneedle
Sham microneedle treatments consisted of pre-treatment with flat microneedle rollers (no needles) and then application of topical 4% lidocaine.
|
|---|---|---|
|
Baseline
STARTED
|
21 21
|
21 21
|
|
Baseline
COMPLETED
|
21 21
|
21 21
|
|
Baseline
NOT COMPLETED
|
0 0
|
0 0
|
|
2 Minutes
STARTED
|
21 21
|
21 21
|
|
2 Minutes
COMPLETED
|
21 21
|
21 21
|
|
2 Minutes
NOT COMPLETED
|
0 0
|
0 0
|
|
5 Minutes
STARTED
|
21 21
|
21 21
|
|
5 Minutes
COMPLETED
|
21 21
|
21 21
|
|
5 Minutes
NOT COMPLETED
|
0 0
|
0 0
|
|
10 Minutes
STARTED
|
21 21
|
21 21
|
|
10 Minutes
COMPLETED
|
21 21
|
21 21
|
|
10 Minutes
NOT COMPLETED
|
0 0
|
0 0
|
|
30 Minutes
STARTED
|
21 21
|
21 21
|
|
30 Minutes
COMPLETED
|
21 21
|
21 21
|
|
30 Minutes
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
Baseline characteristics by cohort
| Measure |
Microneedle Pretreatment
n=21 Forearms
One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Microneedle Roller: 200-micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
Topical 4% lidocaine
|
Sham Microneedle Pretreatment
n=21 Forearms
One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Sham microneedle Roller: Flat roller without microneedles
Topical 4% lidocaine
|
Total
n=42 Forearms
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=21 Forearms
|
29 years
n=21 Forearms
|
29 years
n=42 Forearms
|
|
Sex: Female, Male
Female
|
0 Forearms
n=21 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
0 Forearms
n=21 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
0 Forearms
n=42 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
|
Sex: Female, Male
Male
|
21 Forearms
n=21 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
21 Forearms
n=21 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
42 Forearms
n=42 Forearms • 21 participants studied, each participant had a different treatment on each of their forearms, 42 forearms overall.
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 minPopulation: All participants
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Active Comparator: Microneedle Pretreatment 1 Ventral Forearm
n=21 Forearms
One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
|
Sham Comparator: Sham Microneedle Pretreatment
n=21 Forearms
One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
|
|---|---|---|
|
Visual Analog Scale Pain
|
7 Units on a Scale
Standard Deviation 2
|
12 Units on a Scale
Standard Deviation 3
|
PRIMARY outcome
Timeframe: 5 minPopulation: All participants
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Active Comparator: Microneedle Pretreatment 1 Ventral Forearm
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
|
Sham Comparator: Sham Microneedle Pretreatment
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
|
|---|---|---|
|
Visual Analog Scale Pain
|
11 Units on a Scale
Standard Deviation 2.5
|
15 Units on a Scale
Standard Deviation 4
|
PRIMARY outcome
Timeframe: 10 minPopulation: All participants
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Active Comparator: Microneedle Pretreatment 1 Ventral Forearm
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
|
Sham Comparator: Sham Microneedle Pretreatment
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
|
|---|---|---|
|
Visual Analog Scale Pain
|
8 Units on a Scale
Standard Deviation 3
|
12.5 Units on a Scale
Standard Deviation 3
|
PRIMARY outcome
Timeframe: 30 minPopulation: All participants
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Active Comparator: Microneedle Pretreatment 1 Ventral Forearm
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points
|
Sham Comparator: Sham Microneedle Pretreatment
n=21 Forearm
One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
|
|---|---|---|
|
Visual Analog Scale Pain
|
4 Units on a Scale
Standard Deviation 1.3
|
14.4 Units on a Scale
Standard Deviation 3.8
|
Adverse Events
Microneedle Pretreatment
Sham Microneedle Pretreatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place