Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00305357 |
Other study ID # |
H5612-16138 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 2001 |
Est. completion date |
December 2006 |
Study information
Verified date |
March 2011 |
Source |
University of California, San Francisco |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Evolution of pain and neural injury will be evaluated at 2 years or longer after the onset of
AHZ by multiple measures. Assessments at 2 years or longer will be compared to those
collected during the first 6 months after HZ in order to test whether or not sensory function
and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from
HZ without severe PHN.
Description:
Pain, nerve trunk inflammation, and neuronal injury are hallmarks of acute herpes zoster
(AHZ). We hypothesize that the development of post-herpetic neuralgia (PHN) strongly depends
on two factors: 1) the severity of the initial neural injury and 2) the ability to recover
from the initial neural injury. To test this hypothesis, we will prospectively follow 150
patients at high risk for development of PHN. Evolution of pain and neural injury will be
evaluated at 2-6 weeks, 6 weeks, 3 months, 6 months and at 2 years or longer after the onset
of AHZ by multiple measures. Assessments at 2 years or longer will be compared to those
collected during the first 6 months after HZ in order to test whether or not sensory function
and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from
HZ without severe PHN.
Preliminary analysis of study data showed reduced innervation in HZ skin, mirror image skin
and distant control skin in the acute phase of HZ that was not specific to the persistence of
pain at 3 months. The innervation appeared to recover more fully by 6 months in distant
control skin than in mirror-image skin and HZ skin, despite the fact that the subjects were
continuing to experience a further reduction in their zoster-associated pain. This suggests
that the symptoms of pain and sensory dysfunction are not due to a mere loss in overall
innervation density. The proposed subsequent ≥ 2 year study visit and analysis will allow us
to directly correlate pain resolution with resolution of sensory and innervation
abnormalities.