ORIGINAL ARTICLES   

Giornale Italiano di Dermatologia e Venereologia 2011 June;146(3):185-9

Copyright © 2011 EDIZIONI MINERVA MEDICA

language: English

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

Ionescu M. A. ¹, Baroni A. ², Brambilla L. ³, Cannavò S. P. ⁴, Cristaudo A. ⁵, Dalle Vedove C. ⁶, Frasca M. ⁵, Girolomoni G. ⁶, Gnecchi L. ⁷, Peris K. ⁸, Trifirò C. ⁴, Matta A. M. ⁹, Robert G. ⁹ ✉

¹ Dermatology Polyclinic, Saint-Louis Hospital, Paris, France; ² Unit of Dermatology, University of Naples, Naples, Italy; ³ Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy; ⁴ Dermatological Clinic, University of Messina, Messina, Italy; ⁵ San Gallicano Dermatological Clinic, Rome, Italy; ⁶ Dermatological Clinic, University of Verona, Verona, Italy; ⁷ S. Gerardo University Hospital, Monza, Italy; ⁸ Dermatological Clinic, University of L’Aquila, L’Aquila, Italy; ⁹ Laboratoires Dermatologiques d’Uriage Courbevoie, France

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 Ombelliferae extract with a lipid (TLR2-RegulTM) 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-RegulTM 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-RegulTM (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-RegulTM 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.