PMID- 22182397
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20220409
IS  - 1471-2253 (Electronic)
IS  - 1471-2253 (Linking)
VI  - 11
DP  - 2011 Dec 19
TI  - Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment 
      with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic 
      neuralgia.
PG  - 25
LID - 10.1186/1471-2253-11-25 [doi]
AB  - BACKGROUND: Post-herpetic neuralgia (PHN) is a common type of neuropathic pain 
      that can severely affect quality of life. NGX-4010, a capsaicin 8% dermal patch, 
      is a localized treatment that can provide patients with significant pain relief 
      for up to 3 months following a single 60-minute application. The NGX-4010 
      application can be associated with application-site pain and in previous clinical 
      trials pretreatment with a topical 4% lidocaine anesthetic was used to enhance 
      tolerability. The aim of the current investigation was to evaluate tolerability 
      of NGX-4010 after pretreatment with lidocaine 2.5%/prilocaine 2.5% anesthetic 
      cream. METHODS: Twenty-four patients with PHN were pretreated with lidocaine 
      2.5%/prilocaine 2.5% cream for 60 minutes before receiving a single 60-minute 
      application of NGX-4010. Tolerability was assessed by measuring patch application 
      duration, the proportion of patients completing over 90% of the intended 
      treatment duration, application site-related pain using the Numeric Pain Rating 
      Scale (NPRS), and analgesic medication use to relieve such pain. Safety was 
      assessed by monitoring adverse events (AEs) and dermal irritation using dermal 
      assessment scores. RESULTS: The mean treatment duration of NGX-4010 was 60.2 
      minutes and all patients completed over 90% of the intended patch application 
      duration. Pain during application was transient. A maximum mean change in NPRS 
      score of +3.0 was observed at 55 minutes post-patch application; pain scores 
      gradually declined to near pre-anesthetic levels (+0.71) within 85 minutes of 
      patch removal. Half of the patients received analgesic medication on the day of 
      treatment; by Day 7, no patients required medication. The most common AEs were 
      application site-related pain, erythema, edema, and pruritus. All patients 
      experienced mild dermal irritation 5 minutes after patch removal, which 
      subsequently decreased; at Day 7, no irritation was evident. The maximum recorded 
      dermal assessment score was 2. CONCLUSION: NGX-4010 was well tolerated following 
      pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with PHN. The 
      tolerability of the patch application appeared comparable with that seen in other 
      studies that used 4% lidocaine cream as the pretreatment anesthetic. This study 
      is registered at http://www.clinicaltrials.gov as number NCT00916942.
FAU - Webster, Lynn R
AU  - Webster LR
AD  - Lifetree Clinical Research, Salt Lake City, UT, USA. lrwebstermd@gmail.com.
FAU - Nunez, Margarita
AU  - Nunez M
FAU - Tark, Marvin D
AU  - Tark MD
FAU - Dunteman, Edwin D
AU  - Dunteman ED
FAU - Lu, Biao
AU  - Lu B
FAU - Tobias, Jeffrey K
AU  - Tobias JK
FAU - Vanhove, Geertrui F
AU  - Vanhove GF
LA  - eng
SI  - ClinicalTrials.gov/NCT00916942
PT  - Journal Article
DEP - 20111219
PL  - England
TA  - BMC Anesthesiol
JT  - BMC anesthesiology
JID - 100968535
PMC - PMC3292968
EDAT- 2011/12/21 06:00
MHDA- 2011/12/21 06:01
PMCR- 2011/12/19
CRDT- 2011/12/21 06:00
PHST- 2010/12/03 00:00 [received]
PHST- 2011/12/19 00:00 [accepted]
PHST- 2011/12/21 06:00 [entrez]
PHST- 2011/12/21 06:00 [pubmed]
PHST- 2011/12/21 06:01 [medline]
PHST- 2011/12/19 00:00 [pmc-release]
AID - 1471-2253-11-25 [pii]
AID - 10.1186/1471-2253-11-25 [doi]
PST - epublish
SO  - BMC Anesthesiol. 2011 Dec 19;11:25. doi: 10.1186/1471-2253-11-25.