MIAMI BEACH – An oral Polypodium leucotomos extract supplement was safe and effective for sun protection in a randomized, double-blind, placebo-controlled study of 40 participants.
The plant-based supplement, marketed as Heliocare by Ferndale Healthcare, was associated with a significant reduction in the risk of sunburn and the risk of erythema after ultraviolet B exposure, and with a significant increase in sun tolerability, according to study coauthor Dr. Brian Berman, who presented the findings at the South Beach Symposium.
After 2 months of treatment, 8 of 20 participants in the placebo group experienced at least one episode of sunburn, compared with 2 of 20 in the treatment group. At day 28 of treatment, 1 vs. 8 participants in the placebo and treatment groups, respectively, experienced an increased minimal erythema dose (MED), and 3 vs. 10 experienced decreased ultraviolet-induced erythema intensity (J. Clin. Aesthet. Dermatol. 2015;8:19-23).
Study participants were adults aged 18-65 years with Fitzpatrick skin types I-IV. They took 240-mg Heliocare capsules twice daily for 60 days and were assessed by physical examination. Vital signs were measured and clinical laboratory parameters, including hematology, comprehensive metabolic panel, and prothrombin time-partial thromboplastin time, were assessed at baseline and at the end of treatment. Twelve participants in each group also underwent MED testing. The treatment and placebo groups were similar with respect to the prestudy number of sunburns and the number of hours of sun exposure both before and during the study, said Dr. Berman of the University of Miami.
No safety issues associated with treatment were detected. Four participants in the treatment group reported transient mild fatigue, bloating, and headache, and one in the placebo group reported headache.
Polypodium leucotomos is a South American species of fern. Extracts from the fern have been used for at least 4 decades for photoprotection and for treatment of various skin disorders. The current findings suggest that the supplement is a safe and effective means for reducing the damaging effects of ultraviolet radiation, he said.
As with any dietary supplement, Polypodium leucotomos extract is not approved by the Food and Drug Administration to diagnose, treat, cure, or prevent any disease.
Dr. Berman and his colleagues concluded that, based on the excellent safety profile, additional studies assessing higher doses may be warranted.
Dr. Berman is a consultant/speaker for Ferndale Pharmaceuticals and has relationships with several other pharmaceutical companies.
