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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00524 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RSRB#10077 | Other Identifier | University of Rochester | |
| N01-CN-85183-Step-1-Ext | Other Identifier | DCP | |
| N01CN85183 | Other Identifier | US NIH Grant/Contract Award Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Alice Pentland | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| UV Light Therapy | Procedure | Undergo UV-irradiation |
|
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010789 | Phototherapy |
| D013812 | Therapeutics |