NCT02090933

Celecoxib in Decreasing the Damaging Effects of Sunburn in Healthy Volunteers

Clinical Protocol for an Open Label Study of Celecoxib (SC-58635) on the Acute Effect of Human UV-Irradiation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial studies celecoxib in decreasing the damaging effects of sunburn in healthy volunteers. Celecoxib may reduce skin damage by blocking enzymes associated with sunburn in healthy volunteers.

Detailed description

PRIMARY OBJECTIVES: I. Quantify changes in the erythema response in human subjects exposed to a range of erythemic doses of solar-simulated ultraviolet light before and after celecoxib treatment. II. Collect blood for genetic analysis of markers likely to modulate erythema response. This includes cyclooxygenase (COX), prostaglandin receptor, P53 and excision-repair polymorphisms. OUTLINE: Participants undergo ultraviolet (UV)-irradiation to the right buttock at baseline, receive celecoxib orally (PO) twice daily (BID) for 10 days, and then undergo UV-irradiation to the left buttock. Chromameter readings are obtained 24 hours post UV-irradiation.

Conditions

• No Evidence of Disease

Interventions

Type	Name	Description
DRUG	Celecoxib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	UV Light Therapy	Undergo UV-irradiation

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2014-03-19
• Last updated: 2016-12-29

Locations

1 site across 1 country: United States