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

  • 2012-09
  • Actas dermo-sifiliograficas 103(7)
    • A Ramírez-Bosca
    • P Zapater
    • I Betlloch
    • F Albero
    • A Martínez
    • J Díaz-Alperi
    • J F Horga

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 105
Population
105 patients aged 2-17 years with moderate atopic dermatitis using topical corticosteroids
Methods
Phase IV randomized, double-blind, placebo-controlled, multicenter trial, 6 months of Polypodium leucotomos extract or placebo, assessment of percentage of days with topical corticosteroid use
Blinding
Double-blind
Duration
6 months
Funding
Unclear
  • Large Human Trial

Introduction

Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions.

Objectives

The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity.

Patients and methods

We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated.

Results

Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group.

Conclusion

Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching.

Research Insights

  • Polypodium Leucotomos→Reduced Oral Antihistamine Use

    A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]).

    Effect
    Beneficial
    Effect size
    Small
  • Polypodium Leucotomos→Reduced Topical Corticosteroid Use

    Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo).

    Effect
    Neutral
    Effect size
    Small
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