Fernblock by Cantabria Farmaceutica (Industrial Farmaceutica Cantabria, S.A.)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Actinic keratoses. It is unclear if oral or topical Polypodium leucotomos is beneficial in patients with actinic keratoses. Details: Preliminary clinical research in bald men with at least two visible actinic keratoses on the scalp shows that taking a specific Polypodium leucotomos extract (Fernblock, Industrial Farmaceutica Cantabria) 960 mg daily for one month and then 480 mg daily for 5 months, starting one week after photodynamic therapy, increases the clearance rate of actinic keratoses by a small amount compared with photodynamic therapy alone (99282). Additional preliminary clinical research in patients with severe photoaging and a history of actinic keratoses shows that topical application, alone or in combination with oral administration, of Polypodium leucotomos extract (Fernblock) for 6 months has a large beneficial effect on the percentage of patients with new lesions or requiring new interventions when compared with a control consisting of recommendation for use of sun protection with SPF100. Once patients with new lesions at 6 months were removed from the study to receive further treatment, the percentage of patients with new lesions or requiring new interventions at 12 months was low and not statistically different between groups. The topical product consisted of a gel which was applied twice daily in sun-exposed skin areas. The oral product provided 240 mg once daily (110900). However, a small clinical trial shows that taking Polypodium leucotomos orally 500 mg twice daily for 60 days does not affect total or partial forearm actinic keratosis clearance or the appearance of genetically altered cells when compared with placebo. All patients in this trial were also applying sunscreen SPF30 alone topically to the forearm (110903). This study may have been underpowered to detect any effects of Polypodium leucotomos as it was part of a larger study examining topical treatments.
• Atopic dermatitis (eczema). It is unclear if oral Polypodium leucotomos is beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that taking a Polypodium leucotomos extract (Anapsos, ASAC Pharma) orally might reduce inflammation in young patients with atopic dermatitis (69129). However, other clinical research shows that taking the same product 240-480 mg daily based on age does not improve the clinical course of atopic dermatitis or reduce the need for topical or systemic corticosteroids when compared with placebo in children with this condition (99277).
• Cancer. Although there has been interest in using oral Polypodium leucotomos for cancer prevention, there is insufficient reliable information about the clinical effects of Polypodium leucotomos for this purpose.
• Cutaneous lupus erythematosus (CLE). Although there has been interest in using oral Polypodium leucotomos for CLE, there is insufficient reliable information about the clinical effects of Polypodium leucotomos for this condition.
• Dementia. It is unclear if oral Polypodium leucotomos is beneficial in patients with dementia. Details: Preliminary clinical research in patients with mild to moderate senile dementia shows that taking Polypodium leucotomos extract (Anapsos, ASAC Pharma) 360 mg daily for 4 weeks improves cognition scores. However, taking a higher dose of 720 mg daily does not appear to be effective; the reason for this discrepancy is unclear (69123).
• Melasma. It is unclear if oral Polypodium leucotomos is beneficial in patients with melasma. Details: Evidence for the use of Polypodium leucotomos in melasma is conflicting. Preliminary clinical research in a small group of Hispanic women with moderate to severe facial melasma shows that taking Polypodium leucotomos extract orally 240 mg three times daily for 12 weeks, along with applying sunscreen, does not improve skin pigmentation when compared with placebo and sunscreen application (99278). However, other preliminary clinical research in a small group of Asian women shows that taking a specific Polypodium leucotomos aqueous extract (Fernblock, Industrial Farmaceutica Cantabria) 240 mg twice daily orally for 12 weeks along with topical hydroquinone cream and sunscreen reduces melasma scores by 55%, compared with 44% for placebo plus hydroquinone cream and sunscreen (101470).
• Polymorphous light eruption (PMLE). It is unclear if oral Polypodium leucotomos is beneficial in patients with PMLE. Details: Preliminary clinical research in patients with PMLE shows that taking a specific Polypodium leucotomos extract (Fernblock, Industrial Farmaceutica Cantabria) for 2 weeks helps to prevent ultraviolet light-induced eruptions. Doses were dependent on weight: 720 mg daily in patients up to 55 kg, 960 mg daily in patients 56-70 kg, or 1200 mg daily in patients over 70 kg. After treatment, approximately 30% of patients were protected against eruptions that occurred at the same ultraviolet dose in a prior treatment (99276). Other preliminary clinical research also shows that taking Polypodium leucotomos extract (Difa Cooper) 480 mg daily starting 15 days prior to sun exposure and continuing through sun exposure improves skin reactions and symptoms in approximately 74% of patients with idiopathic photodermatoses, primarily PMLE (99283).
• Psoralen-UVA (PUVA) photodamage. It is unclear if oral or topical Polypodium leucotomos is beneficial for PUVA photodamage prevention. Details: Preliminary clinical research shows that taking a specific Polypodium leucotomos extract (Fernblock, Cantabria Farmaceutica) 7.5 mg/kg on the evening prior to and the day of PUVA treatment can modestly reduce erythema, edema, and signs of epidermal damage. Polypodium leucotomos also seems to decrease subsequent hyperpigmentation in some patients (14366). Other preliminary research also shows that taking a specific Polypodium leucotomos extract (Difur, Cantabria Farmaceutica) 1080 mg daily in four divided doses before sun exposure decreases photodamage in people with psoralen-sensitized skin. Topical application of a lotion containing Polypodium leucotomos extract 10%, 25%, or 50% also seems to reduce photodamage in this population (14476).
• Psoriasis. It is unclear if oral Polypodium leucotomos is beneficial in patients with psoriasis. Details: Preliminary evidence suggests that taking Polypodium leucotomos extracts might improve symptoms of severe psoriasis (14479).
• Sunburn. It is unclear if oral or topical Polypodium leucotomos is beneficial for sunburn prevention. Details: Preliminary clinical research shows that taking two doses of a specific Polypodium leucotomos extract (Fernblock, Cantabria Farmaceutica) 7.5 mg/kg on the evening before and the morning of simulated sun exposure can modestly reduce acute erythema and signs of epidermal damage (14365). Other preliminary clinical research also shows that taking a specific Polypodium leucotomos extract (Difur, Cantabria Farmaceutica) 1080 mg daily in four divided doses before sun exposure decreases photodamage. Topical application of a lotion containing Polypodium leucotomos extract 10%, 25%, or 50% might also reduce photodamage (14476).
• Vitiligo. Preliminary clinical research shows that taking Polypodium leucotomos in conjunction with twice weekly narrow-band ultraviolet B light therapy (NB-UVB) may improve pigmentation of the head and neck in adults with vitiligo, although its effect on other body areas is unclear. Details: Preliminary clinical research in adults with vitiligo that are also undergoing twice weekly NB-UVB shows that taking a specific Polypodium leucotomos extract (Fernblock, Cantabria Laboratories) 480 mg twice daily for 6 months increases moderate repigmentation on the extremities and head and neck area when compared with placebo, with most improvements maintained for at least 3 months. However, repigmentation on other body areas is not improved (105522). Other preliminary clinical research also shows that taking this same Polypodium leucotomos extract (Fernblock) 250 mg three times daily for 25-26 weeks in conjunction with twice weekly NB-UVB light therapy might improve repigmentation in the head and neck area of patients with vitiligo, although repigmentation on other body areas is not improved (69127). Anecdotal evidence also suggests that taking a specific rhizome extract of Polypodium leucotomos (Anapsos, ASAC Pharma) 360 mg daily for 5 months can promote repigmentation in patients with vitiligo (14367). More evidence is needed to rate Polypodium leucotomos for these uses.

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POSSIBLY SAFE ...when used orally and appropriately. Specific Polypodium leucotomos extracts (Fernblock, Cantabria Farmaceutica; Anapsos, ASAC Pharma; others) have been used safely for up to 6 months (14365,14367,14479,99276,99282,99283,101470,105522). The most common doses used have been 360-480 mg daily. Higher doses of 960-1200 mg daily have been used for shorter durations of 2-4 weeks, although a specific extract (Fernblock, Cantabria Laboratories) has been used at a dose of 960 mg daily for 6 months (14365,99276,99282,105522). ...when used topically and appropriately, short-term. A specific Polypodium leucotomos extract (Difur, Cantabria Farmaceutica) has been safely used at doses of up to 50% in a lotion (14476).

CHILDREN: POSSIBLY SAFE
when used orally, short-term. A specific Polypodium leucotomos extract (Anapsos, ASAC Pharma) has been safely used for up to 6 months at doses of 240 mg daily in children aged 2-5 years, 360 mg daily in children aged 6-12 years, and 480 mg daily in children over 12 years of age (99277).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, Polypodium leucotomos might increase levels of drugs metabolized by CYP3A4.  Details In vitro and animal research suggests that Polypodium leucotomos can decrease the metabolism of midazolam by a mechanism possibly related to the inhibition of CYP3A4. However, a small study in humans suggests that taking Polypodium leucotomos with midazolam does not affect the metabolism of midazolam (110894).

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General ...Orally and topically, Polypodium leucotomos seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted on the topical use of Polypodium leucotomos.

Dermatologic ...Orally, Polypodium leucotomos has rarely been associated with pruritus (101470).

Gastrointestinal ...Orally, Polypodium leucotomos has rarely been associated with gastrointestinal symptoms in some patients (14369,101470,110903).

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