Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial

Area of Science:

• Dermatology
• Pharmacology
• Pediatrics

Background:

• Topical corticosteroids are standard treatments for atopic dermatitis, effectively managing inflammation and itching.
• Adverse reactions associated with topical corticosteroids necessitate exploring alternative or adjunctive therapies.
• Atopic dermatitis affects children and adolescents, requiring safe and effective long-term management strategies.

Purpose of the Study:

• To evaluate the efficacy of daily Polypodium leucotomos extract in reducing topical corticosteroid dependency in pediatric atopic dermatitis patients.
• To assess the impact of Polypodium leucotomos extract on oral antihistamine consumption and overall disease severity.
• To investigate the safety and tolerability of long-term Polypodium leucotomos extract use in this population.

Main Methods:

• A phase IV, randomized, double-blind, placebo-controlled, multicenter trial was conducted with 105 pediatric patients (2-17 years) diagnosed with moderate atopic dermatitis.
• Participants received either Polypodium leucotomos extract capsules or a placebo daily for six months, in addition to their standard topical corticosteroid treatment.
• Key outcome measures included the percentage of days requiring topical corticosteroids and oral antihistamines, alongside disease severity assessments.

Main Results:

• Polypodium leucotomos extract did not significantly decrease the mean percentage of days patients used topical corticosteroids compared to placebo (11% vs 12%).
• A statistically significant reduction in the median percentage of days using oral antihistamines was observed in the Polypodium leucotomos group (4.5%) versus the placebo group (13.6%, P=.038).
• The proportion of patients requiring oral antihistamines was notably lower in the Polypodium leucotomos extract group.

Conclusions:

• Long-term daily supplementation with Polypodium leucotomos extract demonstrates a beneficial role in managing atopic dermatitis in children and adolescents.
• The extract shows promise in reducing the need for oral antihistamines, contributing to symptom relief and potentially improving quality of life.
• Further research may explore optimal dosing and combination therapies involving Polypodium leucotomos extract for atopic dermatitis management.