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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02813902
Recruitment Status : Withdrawn (Lack of funding.)
First Posted : June 27, 2016
Last Update Posted : March 8, 2019
Information provided by (Responsible Party):
Maryam M Asgari, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Keratosis, Actinic Keratosis Skin Neoplasms Drug: Heliocare with Fernblock PLE technology Other: Sugar Pill Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Pilot Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

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 Name: 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 Name: Placebo

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02813902

Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Maryam M Asgari, MD, MPH Massachusetts General Hospital
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Responsible Party: Maryam M Asgari, Director, Dermatology High Risk Skin Cancer Clinic, Massachusetts General Hospital Identifier: NCT02813902    
Other Study ID Numbers: 2016P001176
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Neoplasms
Skin Diseases
Precancerous Conditions
Neoplasms by Site