Celecoxib in Decreasing the Damaging Effects of Sunburn in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02090933|
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|No Evidence of Disease||Drug: Celecoxib Other: Laboratory Biomarker Analysis Procedure: UV Light Therapy||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Protocol for an Open Label Study of Celecoxib (SC-58635) on the Acute Effect of Human UV-Irradiation|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
Experimental: Treatment (celecoxib)
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.
Other Name: SC-58635
Other: Laboratory Biomarker Analysis
Procedure: UV Light Therapy
- 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 [ Time Frame: Baseline up to day 11 ]
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): NCT02090933
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Alice Pentland||University of Rochester|