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A Randomized, Placebo-controlled, Double-blind, Phase II Chemoprevention Clinical Trial of Topical Diclofenac and DFMO in Subjects With a History of Skin Cancer
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Birmingham VA Medical Center
Birmingham, Alabama, United States
UAB Dermatology
Birmingham, Alabama, United States
Start Date
January 18, 2021
Primary Completion Date
December 11, 2025
Completion Date
December 11, 2025
Last Updated
December 17, 2025
64
ACTUAL participants
Solaraze and Vaniqa
DRUG
Lead Sponsor
University of Alabama at Birmingham
Collaborators
NCT04844528
NCT03906253
Data Source & Attribution
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