A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity
Status:
Completed
Trial end date:
2011-09-20
Target enrollment:
Participant gender:
Summary
This study will examine the phototoxicity, a reaction to light that is like exaggerated
sunburn, which occurs in people who take medications such as voriconazole, a medication used
to fight fungus. Sunscreens might protect the skin from the reaction. Although phototoxicity
from voriconazole is not completely understood, it may be related to how that medication is
metabolized in the liver by enzymes called cytochrome P450 enzymes-and mainly by one known as
2C19. A way to evaluate phototoxicity is through microarrays, which measure how much each
gene is expressed in cells from tissues such as skin.
Patients ages 8 and older who are scheduled to begin taking or who currently take
voriconazole may be eligible for this study. Also, patients ages 18 to 45 in good health who
have skin tone known as Type 2, which usually burns and tans only slightly following sun
exposure, may be eligible. All patients will visit the Dermatology Clinic. They will complete
two questionnaires, on medical history and medications, as well as the skin response to
sunlight, and donate about 3 teaspoons of blood. Patients who are scheduled to take
voriconazole will visit the clinic four times, that is, two visits 2 consecutive days before
beginning the medication and two visits on 2 consecutive days after taking it for at least 7
days. Each visit will take 1 to 2 hours. Patients about to take voriconazole will have a
blood test and undergo a physical exam of the skin test site, on the buttocks. Researchers
will take photographs of the specific site and do tests to measure skin reaction to
ultraviolet (UV) light. UV light will be shined on 15 small areas of the skin, each 1 x 1
centimeters. After 24 hours, any redness that occurs on the skin will be checked. Afterward,
patients will begin taking voriconazole according to directions by the researchers. At 10 or
more days later, patients will visit the clinic. Sunscreen will be applied and 1 hour later
after administration of voriconazole, a blood sample will be drawn to check the level of
medication. Then UV light will be shined on 23 areas of skin 1 x 1 centimeters. More
photographs will be taken of test sites to record changes in skin redness. On the next day,
the skin response will be evaluated. Participants in the control group will be asked to avoid
UV radiation by wearing hats and clothing, and using sunscreen. They will be given the
doxycycline, an antibiotic, and undergo procedures with UV light shined on small areas of the
skin, on the buttocks. Control participants will have 7 study days, with visits lasting from
1 to 3 hours and probably not exceeding 8 hours. They will have two shave biopsies on Study
Day 2 and on Study Day 7 to determine how the skin has responded to UV light exposures.
Phase:
Phase 1
Details
Lead Sponsor:
National Cancer Institute (NCI) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)