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A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors

NCT02813902 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-03-08

No results posted yet for this study

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.

Conditions

  • Keratosis, Actinic
  • Keratosis
  • Skin Neoplasms

Interventions

DRUG

Heliocare with Fernblock PLE technology

240 mg taken orally daily over the course of 1 year

OTHER

Sugar Pill

A pill that appears similar to the supplement

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Maryam M Asgari, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-05-31
Completion
2020-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813902 on ClinicalTrials.gov