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Ionescu M. A. 1, Brambilla L. 2, Colombo A. 2, Baroni A. 3, Dalle Vedove C. 4, Peris K. 5, Fargnoli M. C. 5, Cristaudo A. 6, Frasca M. 6, Cannavò S. P. 7, Trifirò C. 7, Robert G. 8, Pellicano M. 9, Girolomoni G. 4
1 Dermatology Polyclinic, Saint-Louis Hospital Paris, France;
2 Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;
3 Unit of Dermatology, University of Naples Naples, Italy;
4 Dermatological Clinic, University of Verona, Verona, Italy;
5 Dermatological Clinic, University of L’Aquila, L’Aquila, Italy;
6 San Gallicano Dermatological Clinic, Rome, Italy;
7 Dermatological Clinic, University of Messina, Messina, Italy;
8 Laboratoires Dermatologiques d’Uriage Courbevoie, France;
9 Laboratoires Dermatologiques d’Uriage Italia, Rome, Italy
Aim: Seborrheic dermatitis (SD) is a chronic inflammatory disease aggravated by Malassezia species. Toll-like receptors (TLR) can be activated by yeasts. Previous studies showed that TLR2-Regul®, an association of Ombelliferae extract with a synthetic lipid, decreased the inflammation in human skin in contact with M.furfur and relapses in patients with facial seborrheic dermatitis. Aim of the study was to assess the efficacy and tolerance of a topical formulation based on TLR2-Regul® (without keratolytics and steroids) in patients with scalp seborrheic dermatitis.
Methods: This was a multicentric clinical trial and was made in a series of adults with light to medium SD of the scalp, free of any therapy since at least 8 weeks (were excluded severe SD, immune-suppressed patients and severe SD cases). A hydro-alcoholic lotion for the scalp formulated with TLR2-Regul® and Uriage thermal water was applied 2X/day on the scalp for 30 days; 2 examinations made at baseline and D30. Efficacy criteria on scales, erythema, pruritus were graded on a scale from 0 (cleared) to 9 (very important).
Results: The study included 55 patients, 25 female and 30 male, aged from 21 to 84 years (mean age 43.2). Mean scores for scales, erythema and pruritus decreased significantly at D30 compared to baseline (P<0.01). A very good skin tolerance in 96% of cases.
Conclusion: The use of this lotion decreased significantly, compared to baseline (P<0.01), the clinical scores for erythema, scales and pruritus after 30 days. Toll-like receptors modulation could be an effective and well-tolerated therapeutic alternative in light-medium forms of seborrheic dermatitis of the scalp.