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

March 6, 2019 updated by: Maryam M Asgari, Massachusetts General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Polypodium leucotomos is a tropical fern, the extract of which has shown photoprotective effects in animal and human models, and is currently available as an over-the-counter dietary supplement. Polypodium leucotomos extract (PLE) has been shown in laboratory, animal, and clinical studies to serve as a potent antioxidant that helps mitigate UV-induced damage by scavenging free radicals and reactive oxygen species. Oral consumption of PLE in human studies has been shown to significantly reduce the number if UV-induced sunburn cells and DNA damage, and to inhibit photosensitization. Importantly, PLE appears to be exceptionally well-tolerated with no serious reported adverse side effects.

PLE has been studied in numerous trials for many conditions, including skin diseases. Doses up to 1200 mg per day have been used in clinical studies, though doses for prevention of sun-damage are typically in the range of 480 mg per day. To date, no serious adverse effects have been clearly attributed to the use of PLE (this high tolerability is one of the reasons for the great interest in the clinical use of PLE). Oral consumption of other fern species, such as Polypodium vulgare, have been associated with low blood pressure and increased heart rate. On theoretical grounds, similar side effects may be possible with PLE.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be male or female and at least 18 years of age.

  • Female patients must be of:

    • Non-childbearing potential;
    • Childbearing potential, provided negative urine pregnancy test and using effective contraception.
  • Dermatologist-rendered diagnosis of AK in the past 2 years.

Exclusion Criteria:

  • History of >2 skin cancers in the past 5 years
  • History of dementia
  • Cardiovascular disease, defined as Blood Pressure (BP) <90/60 or Heart rate (HR) >110 in the past year or a history of myocardial infection
  • Inflammatory bowel disease/irritable bowel syndrome
  • Treatment with Fluorouracil, imiquimod, diclofenac, or photodynamic therapy in the past 8 weeks
  • Intention to seek more aggressive AK therapy such as photodynamic therapy, laser surgery in next 12 months
  • Serious psychological illness
  • History of alcohol or drug abuse
  • Any disease or condition which would interfere with study participation or unduly increase risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Heliocare
240 mg administered orally daily
Drug: Heliocare with Fernblock PLE technology
240 mg taken orally daily over the course of 1 year
Other Names:
  • Polypodium leucotomos extract capsules
Placebo Comparator: Sugar pill
a sugar pill matching the Heliocare tablet in look and weight will be administered orally daily
Other: Sugar Pill
A pill that appears similar to the supplement
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of new clinically visable AKs as measured by a full skin exam performed by a blinded, board certified dermatologist (Dr. Asgari).
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Histologic presence of UV-induced cyclobutane pyrimidine dimer positive cells
Time Frame: one year
one year
Degree of solar elastosis assessed using Verhoeff stain on biopsy specimens obtained from punch biopsy
Time Frame: one year
one year
Counts of sunburnt cells in sun exposed skin
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Maryam M Asgari, MD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P001176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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