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Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099136
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
No Evidence of Disease Procedure: UV Light Therapy Other: Placebo Drug: Celecoxib Procedure: Biopsy Other: Imaging Biomarker Analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Quantify changes in the erythema response in human subjects exposed to minimally erythemic doses of solar-simulated ultraviolet light before and after celecoxib treatment.

II. Determine the effect of celecoxib on various biomarkers following ultraviolet (UV)-irradiation. The modulation of the following biomarkers, before and after treatment with celecoxib are being examined: apoptosis and proliferation indices, prostaglandin E2 (PGE2), cyclooxygenase-1 (COX-1), and cyclooxygenase- 2 (COX-2) levels.

OUTLINE:

Patients undergo UV-irradiation to the right buttock at baseline. Chromameter readings are obtained at 24 hours post UV-irradiation and patients undergo skin biopsy at 24 and 96 hours following UV-irradiation.

Patients are then randomized to 1 of 5 treatment groups.

GROUP I: Patients receive placebo orally (PO) twice daily (BID) for 14 days.

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

GROUP III: Patients receive higher dose celecoxib PO BID for 14 days.

GROUP IV: Patients receive same dose of celecoxib PO as Group III once daily (QD) for 14 days.

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

After 10 days post-treatment, patients undergo UV-irradiation to the left buttock. Chromameter readings are obtained at 24 hours post UV-irradiation and patients undergo skin biopsy at 24 and 96 hours following UV-irradiation.

After completion of study treatment, patients are followed up at day 25.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Protocol for a Double-Blind, Placebo-Controlled, Randomized Dose-Ranging Study of Celecoxib (SC-58635) on the Acute Effect of Human UV-Irradiation
Study Start Date : September 1999
Actual Primary Completion Date : September 2001
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Group I (placebo)
Patients receive placebo PO BID for 14 days.
Procedure: UV Light Therapy
Undergo UV-irradiation
Other Names:
  • Light Therapy, UV
  • Therapy, UV Light
  • Ultraviolet Radiation Therapy

Other: Placebo
Given PO
Other Name: PLCB

Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Imaging Biomarker Analysis
Correlative studies

Experimental: Group II (low-dose celecoxib)
Patients receive low-dose celecoxib PO BID for 14 days.
Procedure: UV Light Therapy
Undergo UV-irradiation
Other Names:
  • Light Therapy, UV
  • Therapy, UV Light
  • Ultraviolet Radiation Therapy

Drug: Celecoxib
Given PO
Other Name: SC-58635

Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Imaging Biomarker Analysis
Correlative studies

Experimental: Group III (higher dose celecoxib BID)
Patients receive higher dose celecoxib PO BID for 14 days.
Procedure: UV Light Therapy
Undergo UV-irradiation
Other Names:
  • Light Therapy, UV
  • Therapy, UV Light
  • Ultraviolet Radiation Therapy

Drug: Celecoxib
Given PO
Other Name: SC-58635

Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Imaging Biomarker Analysis
Correlative studies

Experimental: Group IV (higher dose celecoxib QD)
Patients receive same dose of celecoxib PO as Group III QD for 14 days.
Procedure: UV Light Therapy
Undergo UV-irradiation
Other Names:
  • Light Therapy, UV
  • Therapy, UV Light
  • Ultraviolet Radiation Therapy

Drug: Celecoxib
Given PO
Other Name: SC-58635

Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Imaging Biomarker Analysis
Correlative studies

Experimental: Group V (high-dose celecoxib)
Patients receive high-dose celecoxib PO QD for 14 days.
Procedure: UV Light Therapy
Undergo UV-irradiation
Other Names:
  • Light Therapy, UV
  • Therapy, UV Light
  • Ultraviolet Radiation Therapy

Drug: Celecoxib
Given PO
Other Name: SC-58635

Procedure: Biopsy
Undergo skin biopsy
Other Name: Bx

Other: Imaging Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Percent change in erythema [ Time Frame: Baseline up to day 25 ]
    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.

  2. Percent change in PGE2 [ Time Frame: Baseline up to day 25 ]
    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.

  3. Percent change in COX-1 [ Time Frame: Baseline up to day 25 ]
    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.

  4. Percent change in COX-2 [ Time Frame: Baseline up to day 25 ]
    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.

  5. Percent change in proliferative index [ Time Frame: Baseline up to day 25 ]
    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.

  6. Percent change in apoptotic index [ Time Frame: Baseline up to day 25 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

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, 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 abnormal baseline laboratory test > 1.5 x upper limit of normal (ULN) for serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), creatinine, and/or blood urea nitrogen (BUN); all other laboratory abnormalities at baseline thought by the investigator to be clinically significant are also basis for exclusion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099136


Locations
Layout table for location information
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alice Pentland University of Rochester
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02099136    
Other Study ID Numbers: NCI-2014-00525
NCI-2014-00525 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NQ4-99-02-008 ( Other Identifier: University of Rochester )
N01-CN-85183-Step1 ( Other Identifier: DCP )
N01CN85183 ( Other Identifier: US NIH Grant/Contract Award Number )
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action