Conditions: Other Benign Neoplasm of Skin, Unspecified
Keywords: skin cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 184
Healthy volunteers: no

Brief 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.

Detailed 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.

* Eflornithine hydrochloride : Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
* Diclofenac sodium : Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
* Eflornithine hydrochloride/Diclofenac sodium : 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.

Arms:
arm 1: Patients apply Eflornithine HCL ointment to their left forearm twice daily on days 1-90. arm 2: Patients apply topical Diclofenac Na gel to their left forearm once daily on days 1-90. arm 3: Eflornithine HCl ointment and Diclofenac Na gel applied twice and once daily, respectively on days 1-90.

Interventions: intervention 1: Diclofenac Na gel intervention 2: Eflornithine HCL ointment
Intervention descriptions: intervention 1: Given topically twice daily on days 1-90 intervention 2: Given topically twice daily on days 1-90

Protocol document: