title: 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.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dermatology Polyclinic, Saint-Louis Hospital, Paris, France. dr.toni.ionescu@gmail.com
authors.forename: M A
authors.initials: MA
authors.lastname: Ionescu
authors.forename: A
authors.initials: A
authors.lastname: Baroni
authors.forename: L
authors.initials: L
authors.lastname: Brambilla
authors.forename: S P
authors.initials: SP
authors.lastname: Cannavò
authors.forename: A
authors.initials: A
authors.lastname: Cristaudo
authors.forename: C Dalle
authors.initials: CD
authors.lastname: Vedove
authors.forename: M
authors.initials: M
authors.lastname: Frasca
authors.forename: G
authors.initials: G
authors.lastname: Girolomoni
authors.forename: L
authors.initials: L
authors.lastname: Gnecchi
authors.forename: K
authors.initials: K
authors.lastname: Peris
authors.forename: C
authors.initials: C
authors.lastname: Trifirò
authors.forename: A M
authors.initials: AM
authors.lastname: Matta
authors.forename: G
authors.initials: G
authors.lastname: Robert
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019661:Apiaceae; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000382:microbiology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004890:Erythema / Q000188:drug therapy; D005260:Female; D006801:Humans; D016209:Interleukin-8 / Q000187:drug effects / Q000378:metabolism; D008290:Malassezia / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009824:Ointments; D008517:Phytotherapy / Q000379:methods; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy; D055502:Secondary Prevention; D051195:Toll-Like Receptor 2 / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D016209:Interleukin-8; D009824:Ointments; D010936:Plant Extracts; D051195:Toll-Like Receptor 2