Celecoxib in Decreasing the Damaging Effects of Sunburn in Healthy Volunteers

NCT02090933 | Completed Phase 2

• 4 other identifiers: NCI-2014-00524RSRB#10077N01-CN-85183-Step-1-ExtN01CN85183
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

No Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment (celecoxib)

EXPERIMENTAL

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.

Drug: Celecoxib; Other: Laboratory Biomarker Analysis; Procedure: UV Light Therapy

Interventions

Celecoxib DRUG

Given PO

Also known as: SC-58635

Treatment (celecoxib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (celecoxib)

UV Light Therapy PROCEDURE

Undergo UV-irradiation

Also known as: Light Therapy, UV, Therapy, UV Light, Ultraviolet Radiation Therapy

Treatment (celecoxib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Celecoxib; Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phototherapy; Therapeutics

Study Officials

• Alice Pentland

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)