A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors
Status:
Withdrawn
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
This proposal describes a pilot study to gather preliminary evidence of efficacy,
tolerability and toxicity of oral PLE among a high-risk skin cancer population for the
prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal
methods for recruitment, intervention development, data collection, and promoting protocol
adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as
measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The
investigators will also assess histologic markers of Ultra Violet (UV) damage, which have
previously been shown to be reduced with oral PLE use in human studies, namely formation of
UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal
keratinocytes. Results generated from this proposal will form the foundation of a fully
powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also
provide information about this promising dietary supplement which may provide extra
protection for a high-risk skin cancer population.