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Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: No Evidence of Disease

Intervention: UV Light Therapy (Procedure); Placebo (Other); Celecoxib (Drug); Biopsy (Procedure); Imaging Biomarker Analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Alice Pentland, Principal Investigator, Affiliation: University of Rochester

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Percent change in erythema

Percent change in PGE2

Percent change in COX-1

Percent change in COX-2

Percent change in proliferative index

Percent change in apoptotic index

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Rochester, Rochester, New York 14642, United States
Additional Information

Starting date: September 1999
Last updated: March 10, 2015

Page last updated: August 23, 2015

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