A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy

J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):126-33. doi: 10.1097/QAI.0b013e31823e31f7.


Introduction: Effective treatment of HIV-associated distal sensory polyneuropathy remains a significant unmet therapeutic need.

Methods: In this randomized, double-blind, controlled study, patients with pain due to HIV-associated distal sensory polyneuropathy received a single 30-minute or 60-minute application of NGX-4010--a capsaicin 8% patch (n = 332)--or a low-dose capsaicin (0.04%) control patch (n = 162). The primary endpoint was the mean percent change from baseline in Numeric Pain Rating Scale score to weeks 2-12. Secondary endpoints included patient global impression of change at week 12.

Results: Pain reduction was not significantly different between the total NGX-4010 group (-29.5%) and the total control group (-24.5%; P = 0.097). Greater pain reduction in the 60-minute (-30.0%) versus the 30-minute control group (-19.1%) prevented intended pooling of the control groups to test individual NGX-4010 treatment groups. No significant pain reduction was observed for the 30-minute NGX-4010 group compared with 30-minute control (-26.2% vs.-19.1%, respectively, P = 0.103). Pain reductions in the 60-minute NGX-4010 and control groups were comparable (-32.8% vs. -30.0%, respectively; P = 0.488). Posthoc nonparametric testing demonstrated significant differences favoring the total (P = 0.044) and 30-minute NGX-4010 groups (P = 0.035). Significantly, more patients in the total and 30-minute NGX-4010 group felt improved on the patient global impression of change versus control (67% vs. 55%, P = 0.011 and 65% vs. 45%, P = 0.006, respectively). Mild to moderate transient application site pain and erythema were the most common adverse events.

Conclusions: Although the primary endpoint analyses were not significant, trends toward pain improvement were observed after a single 30-minute NGX-4010 treatment.

Trial registration: ClinicalTrials.gov NCT00321672.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Analgesics, Non-Narcotic / administration & dosage*
  • Antipruritics / therapeutic use*
  • Capsaicin / administration & dosage*
  • Double-Blind Method
  • Female
  • Foot Diseases / drug therapy*
  • HIV Infections / complications*
  • HIV Infections / drug therapy
  • Humans
  • Male
  • Middle Aged
  • Neuralgia / drug therapy*
  • Pain Measurement
  • Polyneuropathies / drug therapy*


  • Analgesics, Non-Narcotic
  • Antipruritics
  • Capsaicin

Associated data

  • ClinicalTrials.gov/NCT00321672