Double blind clinical trial in a series of 115 patients with seborrheic dermatitis: prevention of relapses using a topical modulator of Toll like receptor 2

G Ital Dermatol Venereol. 2011 Jun;146(3):185-9.

Abstract

Aim: Seborrheic dermatitis is a chronic inflammatory disease aggravated by Malassezia species. Toll-like receptors (TLR) are part of innate immune system that can be activated by yeasts. Previous studies showed that an association of Umbelliferae extract with a lipid (TLR2-Regul™) decreases the IL-8 expression in human skin in contact with M. furfur. The aim of this study was to assess the activity of a topical formulated with TLR2-Regul™ in the prevention of seborrheic dermatitis (SD) relapses.

Methods: Immune-competent SD adult patients were treated for SD (topical imidazoles or steroids). Cleared patients were randomized and received a topical containing TLR2-Regul™ (A) or its vehicle (B). Erythema, scales and pruritus were assessed during two months.

Results: The study included 115 patients, mean age 43.4, sex ratio m/f 1.5. At week 4 the relapse rate was 26% (N.=15) in group A and 43% (N.=25) in group B. At W8 the relapse rate was 21% (N.=12) in group A and 40% (N.=23) (P=0.0309).

Conclusion: In this series of 115 adults with seborrheic dermatitis, patients treated with a topical containing TLR-Regul™ showed a significantly less relapse rate compared with the excipient group (P<0.05). TLR modulation could represent a new therapeutic approach in the prevention of seborrheic dermatitis relapses.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Aged, 80 and over
  • Apiaceae*
  • Dermatitis, Seborrheic / drug therapy*
  • Dermatitis, Seborrheic / microbiology
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Erythema / drug therapy
  • Female
  • Humans
  • Interleukin-8 / drug effects
  • Interleukin-8 / metabolism
  • Malassezia / drug effects
  • Male
  • Middle Aged
  • Ointments
  • Phytotherapy* / methods
  • Plant Extracts / administration & dosage
  • Plant Extracts / therapeutic use*
  • Pruritus / drug therapy
  • Secondary Prevention
  • Toll-Like Receptor 2 / drug effects*
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Interleukin-8
  • Ointments
  • Plant Extracts
  • Toll-Like Receptor 2