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

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.

Study Overview

• Status: Completed
• Conditions: No Evidence of Disease
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Drug: Celecoxib; Procedure: UV Light Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Celecoxib; Given PO; Other Names: SC-58635; Procedure: UV Light Therapy; Undergo UV-irradiation; Other Names: Light Therapy, UV; Therapy, UV Light; Ultraviolet Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Baseline up to day 11

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: NCI-2014-00524 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); N01CN85183 (Other Identifier: US NIH Grant/Contract Award Number); RSRB#10077 (Other Identifier: University of Rochester); N01-CN-85183-Step-1-Ext (Other Identifier: DCP)