pain Hyperalgesia pain
Conditions
Interventions
UVB irradation
Heat pain assessments.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a physical examination. 2. Body Mass Index (BMI) between 18 and 30kg/m2, inclusive 3. Able to participate and willing to give a written informed consent and to comply with the study restriction.
Exclusion criteria
Exclusion criteria: 1. Any current clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy, etcetc.); 2. History or presence of post-inflammatory hyperpigmentation; 3. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. 4. A positive urine drug screen, or a positive alcohol breath test 5. Use of prescription, over-the-counter, analgesic, illicit or herbal medication within 7 days of nociceptive assessments, except for contraception; 6. Dark skin (Fitzpatrick skin type IV, V or VI), widespread acne, freckles, tattoos or scarring on back; 7. A MED higher than 355 mJ/cm2 at screening. 8. Previous participation in a PainCart® study (CHDR0729, CHDR1311, CHDR1422, CHDR1425, CDHR1431 and CDHR1440); 8. Legal incapacity or inability to understand or comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Thermal pain (normal skin): Pain Detection Threshold (PDT) * Thermal pain (erythema skin): Pain Detection Threshold (PDT) * standardized photography and multispectral imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| * Multispectral imaging (Antera 3D * Miravex) erythema development , melanin variation, * Cross-polarized photography (ATBM - Fotofinder): Erythema Index and Melanin Index * UV flash photography: Melanin disposition * Patient Reported Outcomes (PROs) * Duration visibility, Quality of Life | — |
Countries
Netherlands
Outcome results
None listed