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No Evidence of DiseasePhase 2NCT02099136

Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers

A Phase 2 study testing UV Light Therapy, Celecoxib and Biopsy in people with No Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
No Evidence of Disease
What is being tested?
UV Light Therapy, Celecoxib and Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
Sep 1999to Dec 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
UV Light Therapy, Placebo, Celecoxib, Biopsy, Imaging Biomarker Analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UV Light TherapyProcedure or surgery

    Also called Light Therapy, UV, Therapy, UV Light, Ultraviolet Radiation Therapy

    Undergo UV-irradiation

  • PlaceboOther

    Also called PLCB

    Given PO

  • CelecoxibDrug

    Also called SC-58635

    Given PO

  • BiopsyProcedure or surgery

    Also called Bx

    Undergo skin biopsy

  • Imaging Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02099136
Study groupRoleWhat they receive
Group I (placebo)ExperimentalPatients receive placebo PO BID for 14 days.
Receives: Procedure: UV Light Therapy; Other: Placebo; Procedure: Biopsy; Other: Imaging Biomarker Analysis
Group II (low-dose celecoxib)ExperimentalPatients receive low-dose celecoxib PO BID for 14 days.
Receives: Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis
Group III (higher dose celecoxib BID)ExperimentalPatients receive higher dose celecoxib PO BID for 14 days.
Receives: Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis
Group IV (higher dose celecoxib QD)ExperimentalPatients receive same dose of celecoxib PO as Group III QD for 14 days.
Receives: Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis
Group V (high-dose celecoxib)ExperimentalPatients receive high-dose celecoxib PO QD for 14 days.
Receives: Procedure: UV Light Therapy; Drug: Celecoxib; Procedure: Biopsy; Other: Imaging Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to day 25

  2. 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.

    Measured: Baseline up to day 25

  3. 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.

    Measured: Baseline up to day 25

  4. 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.

    Measured: Baseline up to day 25

  5. 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.

    Measured: Baseline up to day 25

  6. 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.

    Measured: Baseline up to day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study startSep 1999
  3. Primary completionSep 2001
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02099136
Sponsor's protocol ID
NCI-2014-00525
Other IDs
NCI-2014-00525, NQ4-99-02-008, N01-CN-85183-Step1, N01CN85183
Status last verified
Dec 2016
First submitted
25 Mar 2014
Last updated
29 Dec 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UV Light Therapy, Celecoxib and Biopsy in people with No Evidence of Disease, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in erythema (time frame: Baseline up to day 25). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02099136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.

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