Non-melanomatous Skin Cancer Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources
RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused
by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not
yet known whether celecoxib is more effective than a placebo in preventing skin cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing
skin cancer in participants exposed to ultraviolet light.
OBJECTIVES:
- Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects
surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick
type I-IV skin exposed to UV light.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are
randomized to one of two treatment arms.
- Arm I: Participants receive oral celecoxib twice daily for approximately 120 days.
- Arm II: Participants receive oral placebo twice daily for approximately 120 days.
Skin biopsies of UV-exposed sites are evaluated.
Participants are followed for up to 5 weeks post-treatment.
PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study
within 8 months.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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