32
Participants
Start Date
May 8, 2025
Primary Completion Date
May 28, 2025
Study Completion Date
May 28, 2025
Capsaicin only (7.6 ng)
Intradermal injection of 7.6 ng capsaicin (0.5 µM, 50 µL) in synthetic interstitial fluid (SIF) without Flupirtine. Used to induce experimental burning pain in the skin.
Capsaicin + Flupirtine 0.5 µg
Intradermal co-injection of 7.6 ng capsaicin (0.5 µM) and 0.5 µg Flupirtine in 50 µL SIF. Used to assess local analgesic effect of very low-dose Flupirtine on chemically induced pain.
Capsaicin + Flupirtine 1.2 µg
Intradermal co-injection of 7.6 ng capsaicin and 1.2 µg Flupirtine in 50 µL SIF. Part of dose-response evaluation for peripheral pain inhibition.
Capsaicin + Flupirtine 3.0 µg
Intradermal co-injection of 7.6 ng capsaicin and 3.0 µg Flupirtine in 50 µL SIF. Intermediate dose in microdose titration series.
Capsaicin + Flupirtine 7.6 µg
Intradermal co-injection of 7.6 ng capsaicin and 7.6 µg Flupirtine in 50 µL SIF. This is the highest Flupirtine microdose used in the capsaicin model.
Placebo (SIF only, no capsaicin or Flupirtine)
Intradermal injection of 50 µL synthetic interstitial fluid without capsaicin or Flupirtine. Used as negative control for capsaicin-Flupirtine co-injection conditions.
Room Temperature Injection (Control)
Intradermal slow infusion of SIF at \~23°C using a programmable pump. No capsaicin or Flupirtine included. Used as baseline control in heat model.
Heated injection without Flupirtine
Intradermal slow infusion of synthetic interstitial fluid preheated up to \~52°C. No Flupirtine included. Used to induce thermal pain in human skin.
Heated Injection with Flupirtine 124 µg
Intradermal slow infusion of synthetic interstitial fluid up to \~52°C containing 124 µg Flupirtine. Used to test local analgesic effect of high-dose Flupirtine in heat pain model.
Medical University of Vienna, Vienna
Stefan Heber
OTHER