Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

NCT02099136 | Completed Phase 2

• 4 other identifiers: NCI-2014-00525NQ4-99-02-008N01-CN-85183-Step1N01CN85183
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

No Evidence of Disease

Outcome Measures

Primary Outcomes (6)

• Percent change in erythema

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the minimal erythema dose (MED) will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

• Percent change in PGE2

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the MED will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

• Percent change in COX-1

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the MED will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

• Percent change in COX-2

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the MED will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

• Percent change in proliferative index

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the MED will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

• Percent change in apoptotic index

  Descriptive statistics such as mean, median and standard deviation will be calculated. An increase of 50% in the UV dose needed to reach the MED will be considered preliminary evidence of drug activity. The modulation of the biomarkers will be compared to the shift in the erythema response. Summary statistics will be provided for plasma drug levels.

  Baseline up to day 25

Study Arms (5)

Group I (placebo)

EXPERIMENTAL

Patients receive placebo PO BID for 14 days.

Procedure: UV Light Therapy; Other: Placebo; Procedure: Biopsy; Other: Imaging Biomarker Analysis

Group II (low-dose celecoxib)

EXPERIMENTAL

Patients receive low-dose celecoxib PO BID for 14 days.

Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis

Group III (higher dose celecoxib BID)

EXPERIMENTAL

Patients receive higher dose celecoxib PO BID for 14 days.

Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis

Group IV (higher dose celecoxib QD)

EXPERIMENTAL

Patients receive same dose of celecoxib PO as Group III QD for 14 days.

Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis

Group V (high-dose celecoxib)

EXPERIMENTAL

Patients receive high-dose celecoxib PO QD for 14 days.

Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis

Interventions

UV Light Therapy PROCEDURE

Undergo UV-irradiation

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

Group I (placebo); Group II (low-dose celecoxib); Group III (higher dose celecoxib BID); Group IV (higher dose celecoxib QD); Group V (high-dose celecoxib)

Placebo OTHER

Given PO

Also known as: PLCB

Group I (placebo)

Celecoxib DRUG

Given PO

Also known as: SC-58635

Group II (low-dose celecoxib); Group III (higher dose celecoxib BID); Group IV (higher dose celecoxib QD); Group V (high-dose celecoxib)

Biopsy PROCEDURE

Undergo skin biopsy

Also known as: Bx

Group I (placebo); Group II (low-dose celecoxib); Group III (higher dose celecoxib BID); Group IV (higher dose celecoxib QD); Group V (high-dose celecoxib)

Imaging Biomarker Analysis OTHER

Correlative studies

Group I (placebo); Group II (low-dose celecoxib); Group III (higher dose celecoxib BID); Group IV (higher dose celecoxib QD); Group V (high-dose 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 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

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, 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 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Ultraviolet Therapy; Celecoxib; Biopsy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alice Pentland

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: September 1, 1999
• Primary Completion: September 1, 2001
• Study Completion: December 1, 2004
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)