1% capsaicin solution pain model

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-To determine the effect of topical capsaicin on primary hyperalgesia, as assessed by the thermal heat pain test (pain detection thresholds (PDTs))<br>-To determine the effect of topical capsaicin on the area of secondary mechanical allodynia, as assessed with Von Frey filaments (mm2)<br>

Secondary Outcome Measures

Name	Time	Method
-To determine the feasibility of measuring secondary hyperalgesia using LEPs<br>-To determine the intra-individual reproducibility of primary and secondary hyperalgesia/ allodynia measurements with Von Frey, LEPs and thermal heat pain.<br>-To assess the feasibility of incorporating the topical 1% ethanolic capsaicin pain model in the PainCart test battery<br>-To evaluate the effect of capsaicin application on psychophysical, electrophysiological and PainCart parameters<br>