Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects with a History of Skin Cancer

Phase 2

Active, not recruiting

Brief Summary: This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.

Detailed Description: There will be two groups to the study. Individuals, aged 18 years or older, who have extensive actinic damage, at least 8 AKs and a history of at least one non-melanoma skin cancer, but are in otherwise general good health, will be given topical diclofenac and topical DFMO. They will be compared to individuals, aged 18 years or older, who have extensive actinic damage, but are in otherwise general good health, will be given placebo. All participants must be at increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses, and the presence, at baseline, of at least eight actinic keratoses on the face, neck, scalp and arms. Subjects will be randomized to:

1. topical diclofenac once daily and topical DFMO once daily

2. placebo for the topical diclofenac once daily and placebo for the topical DFMO once daily

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Diclofenac + DFMO	Solaraze and Vaniqa	Participants in this arm will apply topical diclofenac to bilateral forearms once per day and topical DFMO to bilateral forearms once per day.
Placebo + Placebo	Solaraze and Vaniqa	Participants in this arm will apply placebo for topical diclofenac to bilateral forearms once per day and placebo for topical DFMO to bilateral forearms once per day.

Primary Outcome Measures

Name	Time	Method
Reduction of actinic keratoses	one year (9 months on active, continuous treatment)	The purpose of the study is to determine whether participants randomized to a combination of two FDA approved topical medications topical diclofenac and topical DFMO have a significant change in incidence of (≥ 50% change, p ≤ 0.05) non-melanoma skin cancers (NMSC) than participants randomized to placebo as assessed by clinical and histopathological evaluation.

Secondary Outcome Measures

Name	Time	Method
Safety assessment	one year (9 months on active, continuous treatment)	Determination of safety of the combination of topical diclofenac and topical DFMO as compared to placebo using the NCI- Common Terminology Criteria for Adverse Events (CTCAE)
Biomarker assessment	one year (9 months on active, continuous treatment)	To assess the effect of topical diclofenac and topical DFMO on the following biomarkers in biopsied non-sun exposed skin, skin tissue that has chronic sun damage, and in actinic keratosis skin lesions at 0 and 9 months: mRNA expression of Sonic Hedgehog, Hip1, Ptch1, Gli1, Gli2, Gli3, and p53, Prostaglandin E2, Proliferation indices (PCNA, cyclin D1), Apoptosis markers (Tunel staining, Bcl-2, caspase-3), Polyamine concentrations (putrescine, spermidine, spermine)
Biomarker assessment of NMSC	one year (9 months on active, continuous treatment)	Effect of topical diclofenac and topical DFMO on biomarkers of squamous cell skin cancer and basal cell skin cancer which include mRNA expression of p53,proliferation indices (PCNA, cyclin D1),apoptosis markers (Tunel staining, Bcl-2, caspase-3), andmarkers of epithelial adhesion (E-cadherin)

Locations (2): Birmingham VA Medical Center
🇺🇸
Birmingham, Alabama, United States
UAB Dermatology
🇺🇸
Birmingham, Alabama, United States

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial