Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

Non-melanomatous Skin Cancer Clinical Trial

Official title: Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm

Status Completed

Clinical Trial Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin.

PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.

Clinical Trial Description

OBJECTIVES:

Primary

• To determine if combination therapy with topical eflornithine hydrochloride ointment and topical diclofenac sodium gel over 3-months increases the efficacy versus either agent used alone in the treatment of moderately sun-damaged skin.

Secondary

• To evaluate the safety of sequential administration of topical eflornithine hydrochloride ointment and topical diclofenac sodium gel.

• To determine the correlation of karyometric changes with histopathologic, immunohistochemical, clinical, and genetic polymorphism data.

• To obtain materials for microarray analysis.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.

• Arm II: Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.

• Arm III: Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.

Prior to treatment, three 4-mm punch biopsies are taken from the skin of the left lateral forearm for assessment of histopathology, the cyclooxygenase-2 enzyme and p53 expression, apoptosis, and nuclear chromatin karyometry. Tissue is also obtained for future use in microarray analysis. Blood is drawn for assessment of ornithine decarboxylase polymorphisms and for banking for subsequent studies. Biopsies are repeated 2-3 weeks after completion of treatment.

Digital photographs are taken at baseline and 1-2 weeks after completion of study therapy to document improvement of sun damage, appearance of new skin lesions, and toxicity. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Non-melanomatous Skin Cancer
• Skin Neoplasms

• NCT number: NCT00601640
• Study type: Interventional
• Source: University of Arizona
• Status: Completed
• Phase: Phase 2
• Start date: January 2007
• Completion date: January 2010