Celecoxib in Decreasing the Damaging Effects of Sunburn in Healthy Volunteers

NCT ID: NCT02090933

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2004-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment (celecoxib)

Participants undergo UV-irradiation to the right buttock at baseline, receive celecoxib PO BID for 10 days, and then undergo UV-irradiation to the left buttock.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

UV Light Therapy

Intervention Type: PROCEDURE

Undergo UV-irradiation

Interventions

Celecoxib

Given PO

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

UV Light Therapy

Undergo UV-irradiation

Intervention Type: PROCEDURE

Other Intervention Names

SC-58635; Light Therapy, UV; Therapy, UV Light; Ultraviolet Radiation Therapy

Eligibility Criteria

Inclusion Criteria

• The subject has 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
• Will begin taking study drug beginning 2 days after onset of menses
• The subject is willing to abstain from the use of other 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 with the exception of lotion
• 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, connective tissue disorder, or any disease that would increase the risk associated with study participation
• The study 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; 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 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 a known hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, or NSAIDs
• The subject has significant medical or psychosocial problems that would make the subject a poor candidate, in the opinion of the principal investigator
• The subject is currently taking celecoxib

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Pentland

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

NCI-2014-00524

Identifier Type: REGISTRY

Identifier Source: secondary_id

RSRB#10077

Identifier Type: OTHER

Identifier Source: secondary_id

N01-CN-85183-Step-1-Ext

Identifier Type: OTHER

Identifier Source: secondary_id

N01CN85183

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2014-00524

Identifier Type: -

Identifier Source: org_study_id