NCT02099136

Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

Clinical Protocol for a Double-Blind, Placebo-Controlled, Randomized Dose-Ranging Study of Celecoxib (SC-58635) on the Acute Effect of Human UV-Irradiation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• No Evidence of Disease

Interventions

Type	Name	Description
PROCEDURE	UV Light Therapy	Undergo UV-irradiation
OTHER	Placebo	Given PO
DRUG	Celecoxib	Given PO
PROCEDURE	Biopsy	Undergo skin biopsy
OTHER	Imaging Biomarker Analysis	Correlative studies

Timeline

• Start date: 1999-09-01
• Primary completion: 2001-09-01
• Completion: 2004-12-01
• First posted: 2014-03-28
• Last updated: 2016-12-29

Locations

1 site across 1 country: United States