Trial Outcomes & Findings for Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study (NCT NCT02537951)
NCT ID: NCT02537951
Last Updated: 2019-06-11
Results Overview
AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli
COMPLETED
NA
10 participants
Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)
2019-06-11
Participant Flow
all 10 healthy volunteers underwent 3 experiments, all 10 have completed these experiments: 1. AFI intensity measurements 2. lidocaine/prilocaine creme, one hour later followed by AFI intensity measurements 3. capsaicin patch (2 hours after lidocaine/prilocaine creme), one week later followed by AFI intensity measurements
Participant milestones
| Measure |
10 Healthy Volunteers
10 healthy volunteers underwent three procedures, always in the same order:
1. baseline AFI measurements
2. application of lidocaine/prilocaine creme, 1 hour later followed by AFI measurements
3. application of capsaicin patches, 1 week later followed by AFI measurements
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|---|---|
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Overall Study
STARTED
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10
|
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Overall Study
COMPLETED
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10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AFI Intensity in Healthy Volunteers
n=10 Participants
10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope
AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities
After AFI intensity measurements, the same experiment will be repeated one hour after application of lidocaine/prilocaine creme
After the negative control experiment using lidocaine/prilocaine creme, AFI intensity measurements will be repeated one week after application of a capsaicin 8% patch (second negative control experiment)
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|---|---|
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Age, Continuous
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25 years
n=10 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
Netherlands
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli
Outcome measures
| Measure |
AFI Intensity in Healthy Volunteers
n=10 Participants
10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope
AFI microscope: measurement of AFI intensities following increasing nociceptive stimulus intensities
|
Negative Control 1: Lidocaine/Prilocaine
n=10 Participants
10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1hour after application of lidocaine/prilocaine creme (negative control 1)
negative control 1: lidocaine/prilocaine: measurement of AFI intensities following lidocaine/prilocaine cream
|
Negative Control 2: 8% Capsaicin
n=10 Participants
-10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1week after application of an 8% capsaicin patch (negative control 2)
negative control 2: 8% capsaicin: measurement of AFI intensities following 8% capsaicin patch
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|---|---|---|---|
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AFI-intensity After Nociceptive Stimulation
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0.60 unitless
Standard Error 0.25
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0.25 unitless
Standard Error 0.25
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0.50 unitless
Standard Error 0.50
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Adverse Events
AFI Intensity in Healthy Volunteers
Negative Control 1: Lidocaine/Prilocaine
Negative Control 2: 8% Capsaicin
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