Capsaicin pain model with topical 1% ethanolic capsaicin solutio
- Conditions
- PainNeuropathic pain
- Registration Number
- NL-OMON48384
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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 <p>-Pain Detection Threshold (PDT) on capsaicin treated area compared with<br /><br>untreated area (°C), assessed with Q-Sense<br /><br>-Area of secondary mechanical allodynia around the capsaicin treated area<br /><br>(mm2), assessed with Von Frey hair stimulation </p><br>
- Secondary Outcome Measures
Name Time Method