A Phase 1 interventional study of Heliocare with Fernblock PLE technology and Sugar Pill in Keratosis, Actinic, Keratosis and Skin Neoplasms, sponsored by Massachusetts General Hospital. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Massachusetts General Hospital · Phase 1, Interventional, and Health services research
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.
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
Browse Keratosis, Actinic studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Female patients must be of:
Exclusion Criteria:
240 mg administered orally daily
Drug: Heliocare with Fernblock PLE technology
a sugar pill matching the Heliocare tablet in look and weight will be administered orally daily
Other: Sugar Pill
240 mg taken orally daily over the course of 1 year
Also known as: Polypodium leucotomos extract capsules
A pill that appears similar to the supplement
Also known as: Placebo
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
Histologic presence of UV-induced cyclobutane pyrimidine dimer positive cells
Time frame: one year
Degree of solar elastosis assessed using Verhoeff stain on biopsy specimens obtained from punch biopsy
Time frame: one year
Counts of sunburnt cells in sun exposed skin
Time frame: one year
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital