Pain Neuropathic pain
Conditions
Interventions
50uL of 1% capsaicin in ethanolic solution applied topically on the volar
forearm
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs. ;2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive. ;3. Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. ;2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. ;3. History of alcohol or drug abuse;4. Participation in an investigational drug or device study within 3 months prior to screening. ;5. Any confirmed significant allergic reactions (urticaria or anaphylaxis) after previous exposure to capsaicin ;6. Subject indicating intolerable pain after capsaicin administration at screening;7. Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (i.e., disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy) ;8. Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests.;9. Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the volar forearms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Pain Detection Threshold (PDT) on capsaicin treated area compared with untreated area (°C), assessed with Q-Sense -Area of secondary mechanical allodynia around the capsaicin treated area (mm2), assessed with Von Frey hair stimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pain Detection Threshold (PDT) on capsaicin treated area compared with untreated area (°C), assessed with Q-Sense -Area of secondary mechanical allodynia around the capsaicin treated area (mm2), assessed with Von Frey hair stimulation -Amplitude (*V ) and latency (ms) of LEPs in primary, secondary, and control area (N2, P2, and N2P2) -Electrical Burst: PDT (mA), Pain Tolerance Threshold (PTT) (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm). -Electrical Stair (pre-cold pressor): PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS (mm). -Electrical Stair (post-cold pressor): PDT (mA), PTT (mA), AUC (mA*mm), and post-test VAS (mm). -Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor): PDT (mA), PTT (mA), AUC (mA*mm). -Pressure Pain: PDT (kPa), PTT (kPa), AUC (kPa*mm), and post-test VAS (mm). -Cold Pressor: PDT (s), PTT (s), AAC (s*mm), and post-test VAS (mm). -Capsaicin pain - Numeric Rating Scale (NRS): Numeric Rating Scale (0-10 with 0=no pain & 10=worst pain imaginable) -Subjective pain perception after LS on primary, secondary and control area +LS-NRS: Numeric rating scale (0-10 with 0=no pain & 10=worst pain imaginable) +McGill Pain Questionnaire | — |
Countries
Netherlands
Outcome results
None listed