Celecoxib in Decreasing the Damaging Effects of Sunburn in Healthy Volunteers

No Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090933
• Other study ID #: NCI-2014-00524
• Secondary ID: NCI-2014-00524RS
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2014
• Last updated: December 28, 2016
• Start date: March 2004
• Est. completion date: December 2004

Study information

• Verified date: December 2016
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• No Evidence of Disease

Intervention

Drug:
• Celecoxib
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• UV Light Therapy
Undergo UV-irradiation

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No