Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• The subject as Fitzpatrick skin type I, II, or III

• If the subject is female and of childbearing potential (women are considered not of childbearing potential if they are at least 2 years post-menopausal and/or surgically sterile):

• Has been using adequate contraception (e.g., condom, intrauterine device [IUD], diaphragm and spermicide gel combination) since her last menses and will use adequate contraception during the study, AND

• Is not lactating, AND

• Has had a negative pregnancy test (serum or urine) within 14 days prior to the first dose of study medication

• The subject is willing to abstain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) for the duration of the study

• The subject is willing to abstain from the use of all topical agents applied to the buttocks for the duration of the study

• The subject is willing to participate for the duration of the study

• The subject has provided written informed consent prior to administration of any study related procedures

Exclusion Criteria:

• The subject is currently taking any medication that may alter the sunlight response or cause an adverse reaction

• The subject has a history of melanoma, lupus, psoriasis, rosacea, porphyria, photosensitivity disorder, keloid formation, connective tissue disorder, or any disease that would increase the risk associated with study participation

• The subject has excessive hair, blemishes, nevi, uneven pigmentation, sunburn or suntan on the buttocks

• The subject has sun bathed or used a tanning bed to expose the buttocks within 12 months of admission to the study

• The subject has inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a chronic or acute renal or hepatic disorder or a significant coagulation defect or any other condition which in the investigator's opinion might preclude use of an NSAID (e.g., congestive heart failure)

• The subject has an active malignancy of any type or history; subjects who have a history of nonmelanoma skin cancer and have been treated are acceptable; subjects with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrollment are also acceptable

• The subject has active or suspected peptic ulceration or gastrointestinal bleeding

• The subject has abnormal baseline laboratory test > 1.5 x upper limit of normal (ULN) for serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), creatinine, and/or blood urea nitrogen (BUN); all other laboratory abnormalities at baseline thought by the investigator to be clinically significant are also basis for exclusion

• The subject has received any investigational medication within 30 days prior to the first dose of study medication or is scheduled to receive an investigational drug other than celecoxib during the course of this study

• The subject has known hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, or NSAIDs

• The subject has been previously admitted to this study

• The subject has significant medical or psychosocial problems that would make the subject a poor candidate, in the opinion of the principal investigator