No Evidence of Disease Clinical Trial
Official title:
Clinical Protocol for a Double-Blind, Placebo-Controlled, Randomized Dose-Ranging Study of Celecoxib (SC-58635) on the Acute Effect of Human UV-Irradiation
This randomized clinical trial studies if celecoxib will prevent the damaging effects of sunburn in healthy volunteers. Exposure to ultraviolet light can induce erythema, sunburn or skin redness caused by inflammation. Celecoxib may reduce skin damage by blocking enzymes associated with sunburn in healthy volunteers. Studying samples of skin in the laboratory from patients receiving ultraviolet-radiation before and after celecoxib treatment may help doctors learn more about the effects celecoxib has on cells.
PRIMARY OBJECTIVES:
I. Quantify changes in the erythema response in human subjects exposed to minimally
erythemic doses of solar-simulated ultraviolet light before and after celecoxib treatment.
II. Determine the effect of celecoxib on various biomarkers following ultraviolet
(UV)-irradiation. The modulation of the following biomarkers, before and after treatment
with celecoxib are being examined: apoptosis and proliferation indices, prostaglandin E2
(PGE2), cyclooxygenase-1 (COX-1), and cyclooxygenase- 2 (COX-2) levels.
OUTLINE:
Patients undergo UV-irradiation to the right buttock at baseline. Chromameter readings are
obtained at 24 hours post UV-irradiation and patients undergo skin biopsy at 24 and 96 hours
following UV-irradiation.
Patients are then randomized to 1 of 5 treatment groups.
GROUP I: Patients receive placebo orally (PO) twice daily (BID) for 14 days.
GROUP II: Patients receive low-dose celecoxib PO BID for 14 days.
GROUP III: Patients receive higher dose celecoxib PO BID for 14 days.
GROUP IV: Patients receive same dose of celecoxib PO as Group III once daily (QD) for 14
days.
GROUP V: Patients receive high-dose celecoxib PO QD for 14 days.
After 10 days post-treatment, patients undergo UV-irradiation to the left buttock.
Chromameter readings are obtained at 24 hours post UV-irradiation and patients undergo skin
biopsy at 24 and 96 hours following UV-irradiation.
After completion of study treatment, patients are followed up at day 25.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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