NCT02813902

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

Withdrawn Phase 1 Last updated 6 March 2019

What this trial tests

Phase 1 trial testing Heliocare with Fernblock PLE technology in Keratosis, Actinic. Withdrawn.

Timeline

1 July 2019

Primary endpoint
1 May 2020

1 May 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Start date	1 July 2019
Primary completion	1 May 2020
Estimated completion	1 May 2020

Drugs / interventions tested

• Heliocare with Fernblock PLE technology — full drug profile →
• Sugar Pill

Conditions studied

• Keratosis, Actinic — all drugs for Keratosis, Actinic →
• Keratosis — all drugs for Keratosis →
• Skin Neoplasms — all drugs for Skin Neoplasms →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Keratosis, Actinic or Keratosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials.
   Jeter JM, Bowles TL, Curiel-Lewandrowski C, Swetter SM, et al · · 2019 · cited 23× · PMID 30281145 · DOI 10.1002/cncr.31719