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

NCT02813902 | Withdrawn Phase 1 DMC

• 1 other identifier: 2016P001176
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Keratosis, Actinic; Keratosis; Skin Neoplasms

Outcome Measures

Primary Outcomes (1)

• Total number of new clinically visable AKs as measured by a full skin exam performed by a blinded, board certified dermatologist (Dr. Asgari).

  one year

Secondary Outcomes (3)

• Histologic presence of UV-induced cyclobutane pyrimidine dimer positive cells

  one year

• Degree of solar elastosis assessed using Verhoeff stain on biopsy specimens obtained from punch biopsy

  one year

• Counts of sunburnt cells in sun exposed skin

  one year

Study Arms (2)

Heliocare

ACTIVE COMPARATOR

240 mg administered orally daily

Drug: Heliocare with Fernblock PLE technology

Sugar pill

PLACEBO COMPARATOR

a sugar pill matching the Heliocare tablet in look and weight will be administered orally daily

Other: Sugar Pill

Interventions

Heliocare with Fernblock PLE technology DRUG

240 mg taken orally daily over the course of 1 year

Also known as: Polypodium leucotomos extract capsules

Heliocare

Sugar Pill OTHER

A pill that appears similar to the supplement

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis; Skin Neoplasms

Interventions

Sugars

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Maryam M Asgari, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dermatology High Risk Skin Cancer Clinic

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 27, 2016
• Study Start: July 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03