PL Extract in Children

Cantabria Labs can’t officially recommend any age limit as we have not conducted studies ourselves. Recommendation in these cases should be left to medical professionals, who can assess risk-benefit. If inquired, the literature shows safety of oral PL in children as per the study mentioned below (not conducted by Cantabria Labs). Researchers demonstrated safety in children below age of 6.

As “unofficial” but useful opinion, Dr. Salvador Gonzalez, main researcher on PL and a collaborator of Cantabria Labs for a long time, suggests avoiding oral PL use in children below age 4, since the skin’s immune system is not fully developed until that age (as you know, PL interacts with the skin’s immune defenses).

(https://www.sciencedirect.com/science/article/abs/pii/S1578219012002235):

 

Cantabria Labs has conducted no specific safety testing on children. An important study was published, however, regarding the use of PL in children suffering from atopic dermatitis. A total of 105 children were involved, 52 PL and 53 placebo. The average age in the PL group was 7.45 years, 48% < 6 years, 35% 6-12 years, and 17% > 12 years. PL dosages were 240mg at night for children < 6 years, 120mg morning and 240 mg night 6-12 years, and 240mg + 240mg >12 years. The study was conducted over a 6-month period. Concomitant therapies included topical corticosteroids (methylprednisolone aceponate 0.1%), oral corticosteroids (deflazacort 0.25 – 1.5 mg/kg/d), oral antihistamine (desloratadine) and topical moisturisers/emollients.

 

There was no statistical difference in adverse effects between the PL group and placebo, suggesting that PL causes no discernible side effects in children. Adverse effects appeared to be coincidental, or at most, due to concomitant therapies. In total, 463 adverse events were recorded over the study period: 218 in the PL extract group and 223 in the placebo group. In both groups, most of the events were classified as mild. Moderate adverse events were more common in the placebo group (14 patients) than in the PL extract group (7 patients) (Table 3). Only 1 patient, receiving placebo, experienced a severe adverse event (diarrhea with dehydration).

 

Table 3 Moderate to Severe Adverse Events During Study

 

 

Polypodium leucotomos Extract

Group (n = 7)

Placebo Group (n = 15)

 

Moderate

 

• Broncospasm episode

• Lip swelling

• Chickenpox

• Cold

• Pharyngoamigalitis (n = 2)

• Cough and cold

 

• Diarrhea

• Flu-bronchitis (n = 3)

• Fever (n = 2)

• Pharyngotonsillitis

• Acute flare of atopic dermatitis

• Intense pruritus

• Tinea capitis

• Eczema superinfection

• Back pain

• Mesenteric adenitis                                   NS

Serious

 

•Diarrhea with dehydration                       NS

Abbreviation: NS, non-significant difference

 

The authors concluded that “The good safety profile of PL extract, which was not associated with a perceivable increase in risk under the study conditions, indicates that it can be prescribed as a long-term treatment”.

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