Trial Outcomes & Findings for Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy (NCT NCT01086150)

Results Overview

Scores range from 0 to 10 with higher scores indicating higher levels of pain.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

51 participants

Primary outcome timeframe

baseline, 4 weeks

Results posted on

2020-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Control Patients Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Type I or Type II Diabetes With Painful Diabetic Neuropathy 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Patients With Non-painful Diabetic Peripheral Neuropathy 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.
Overall Study STARTED	11	27	13
Overall Study COMPLETED	11	21	12
Overall Study NOT COMPLETED	0	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Type I or Type II Diabetes With Painful Diabetic Neuropathy 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Patients With Non-painful Diabetic Peripheral Neuropathy 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	1	0
Overall Study Screen Failure	1	0

Baseline Characteristics

Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control Patients n=11 Participants Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Type I or Type II Diabetes With Painful Diabetic Neuropathy n=21 Participants 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Patients With Non-painful Diabetic Peripheral Neuropathy n=12 Participants 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 4 weeks

Population: Healthy controls were not assessed for this measure.

Scores range from 0 to 10 with higher scores indicating higher levels of pain.

Outcome measures

Outcome measures
Measure	Healthy Control Patients Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Type I or Type II Diabetes With Painful Diabetic Neuropathy n=21 Participants 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Patients With Non-painful Diabetic Peripheral Neuropathy n=12 Participants 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.
Pain Scores From Composite Visual Analog Scale Baseline	—	6.5 units on a scale Interval 4.5 to 9.0	1.2 units on a scale Interval 0.0 to 3.1
Pain Scores From Composite Visual Analog Scale 4 weeks	—	4.5 units on a scale Interval 0.0 to 8.9	0.5 units on a scale Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Pixel intensity (0-256) of immunofluorescence for each individual biomarker.

Outcome measures

Outcome measures
Measure	Healthy Control Patients n=11 Participants Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Type I or Type II Diabetes With Painful Diabetic Neuropathy n=21 Participants 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.	Patients With Non-painful Diabetic Peripheral Neuropathy n=12 Participants 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove.
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP Nav1.6-baseline	81.2 Pixel intensity (0-256) Interval 63.54 to 127.38	101.4 Pixel intensity (0-256) Interval 64.69 to 135.5	87.9 Pixel intensity (0-256) Interval 49.3 to 126.44
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP Nav1.6-4 weeks	91 Pixel intensity (0-256) Interval 49.19 to 132.37	90.7 Pixel intensity (0-256) Interval 60.85 to 134.63	90.8 Pixel intensity (0-256) Interval 60.38 to 148.07
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP Nav1.7-baseline	47.5 Pixel intensity (0-256) Interval 30.84 to 73.33	59.6 Pixel intensity (0-256) Interval 39.41 to 87.53	54.3 Pixel intensity (0-256) Interval 40.66 to 66.9
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP Nav1.7-4 weeks	52.4 Pixel intensity (0-256) Interval 39.82 to 85.83	51.5 Pixel intensity (0-256) Interval 30.3 to 81.35	54.7 Pixel intensity (0-256) Interval 34.43 to 77.57
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP CGRP-baseline	27.7 Pixel intensity (0-256) Interval 22.37 to 32.83	38.5 Pixel intensity (0-256) Interval 27.49 to 68.14	29.5 Pixel intensity (0-256) Interval 19.51 to 39.83
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP CGRP-4 weeks	31.5 Pixel intensity (0-256) Interval 21.86 to 49.53	32.8 Pixel intensity (0-256) Interval 19.03 to 56.1	26.2 Pixel intensity (0-256) Interval 20.52 to 36.58

Adverse Events

Healthy Control Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Type I or Type II Diabetes With Painful Diabetic Neuropathy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With Non-painful Diabetic Peripheral Neuropathy

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

Charles E. Argoff, MD

Albany Medical College

Phone: 518 262-0034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place