To assess if the irradiation of 2MED UVB induces a significant level of hyperalgesia to be used in the UVB pain model
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Thermal pain (normal skin): Pain Detection Threshold (PDT)
* Thermal pain (erythema skin): Pain Detection Threshold (PDT)
* standardized photography and multispectral imaging
Secondary outcome
* 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
Background summary
The PainCart is a test battery of human evoked pain models which is able to
measure biomarkers for nociceptive and inflammatory pain at early stages of
drug development in healthy volunteers. As such, this method can be utilized as
a decision making tool for pharmaceutical companies in order to determine
Proof-of-Pharmacology and to guide dose selection. One of the models used is
the ultraviolet (UV) B pain model to examine possible analgesics. This test
uses controlled predefined narrow-band UVB radiation to induce skin erythema
and hyperalgesia, subsequent hyperalgesia is quantified using a thermode. In
the past 3 years the UVB heat pain assessment has been used in several studies.
However some subjects have returned with complaints of hyperpigmented areas of
skin on their back that have not yet faded. These areas are presumably caused
by the UVB dose used in these subjects.
Study objective
To assess if the irradiation of 2MED UVB induces a significant level of
hyperalgesia to be used in the UVB pain model
Study design
Method validation study
Intervention
UVB irradation
Heat pain assessments.
Study burden and risks
This is a method validation study for the use of 2MED in the UVB heat pain
assessment. In the current validated method, a dose of 3MED UVB is used to
irradiate the skin. This dosage is well tolerated by subjects, except for the
risk of development of post-inflammatory hyperpigmentation (PIH). The
development of PIH was to our knowledge not a known risk factor at the time of
performing the previous studies. In literature, Brenner et aAl. mention one
subject which had hyperpigmented areas visible 520 days
post-irradiationirradiation (13). Post-inflammatory hyperpigmentation is a
usually harmless condition in which areas of skin become darker in color
compared to the surrounding skin. PIH can occur at any age and any skin type,
however it is more common in people with Fitzpatrick skin type 4-6.(14, 15) By
decreasing the UVB dose to 2MED, the exposure to UVB is reduced. Additionally,
excluding subjects with a Fitzpatrick skin type 3 or higher will further reduce
the risk to develop PIH. Participation in this study does not have any benefit
for health. However, the study will provide valuable information for further
research.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63598.056.17 |