Clinical and Biochemical Assessment of Maintenance Treatment in Chronic Recurrent Seborrheic Dermatitis: Randomized Controlled Study

Dermatology and Therapy - Tập 4 - Trang 43-59 - 2014
Virginie Turlier1, Cécile Viode2, Elisabeth Durbise3, Adeline Bacquey4, Ophélie LeJeune2, Rui Oliveira Soares5, Christophe Lauze6, Cécile Villeneuve2, Amandine Rouquier1, Christiane Casas2, Daniel Redoules7, Valérie Mengeaud1, Anne-Marie Schmitt8
1Service Exploration Clinique, Hôtel Dieu, Toulouse, France
2Service de Biologie Clinique, Hôtel Dieu, Toulouse, France
3Cahors, France
4Service Systemes et Methodes, Hôtel Dieu, Toulouse, France
5Hospital Cuf Descobertas-Parque das Nações, Lisbon, Portugal
6Pierre Fabre Biométrie, Labège Innopole, France
7Service Pharmacologie Clinique, Hôtel Dieu, Toulouse, France
8Centre de Recherche sur la Peau, Hôtel Dieu, Toulouse, France

Tóm tắt

Few studies have investigated the long-term effects of a maintenance regimen in the prevention of relapses in scalp seborrheic dermatitis (SD), in particular following biomarker changes. A new shampoo containing beta-glycyrrhetinic acid (18βGA) in addition to cyclopiroxolamine (CPO) and zinc pyrithione (ZP) was tested in 67 subjects suffering from SD with moderate to severe erythema and itching in a biphasic study. After a first common intensive treatment phase (investigational product thrice a week × 2 weeks), subjects randomly received the investigational product once a week × 8 weeks (maintenance) or a neutral shampoo (discontinuation) in a comparative, parallel group maintenance phase. Efficacy was assessed clinically (overall clinical dandruff score, erythema, overall efficacy, self-evaluation), biochemically and microbiologically by quantitative polymerase chain reaction (qPCR), high performance liquid chromatography (HPLC) or enzyme-linked immunoabsorbent assay (ELISA) analysis of scale samples (Malassezia species (restricta and globosa), cohesion proteins (plakoglobins), inflammation (Interleukin (IL)-8, IL-1RA/IL-1α) and pruritus (histamine, cathepsin S) markers). During the intensive treatment phase, SD improved significantly (p < 0.0001) with a decrease in clinical signs as well as Malassezia species, cohesion proteins, inflammation and pruritus markers. During the maintenance phase, the improvement persisted in the ‘maintenance’ group only, with a significant intergroup difference. A consistently positive relationship was found between dandruff, itching, erythema and Malassezia populations, histamine levels and IL-1RA/IL-1α ratio. The effectiveness of this maintenance regimen was objectively demonstrated at the clinical, biochemical and microbiological level. Correlations between clinical signs and biomarkers could provide clues to explain the resolution of SD and confirm the interest of biomarkers for SD treatment assessment.

Tài liệu tham khảo

Foley P, Zuo Y, Plunkett A, Merlin K, Marks R. The frequency of common skin conditions in preschool-aged children in Australia: seborrheic dermatitis and pityriasis capitis (cradle cap). Arch Dermatol. 2003;139:318–22.

Lorette G, Ermosilla V. Clinical efficacy of a new ciclopirox olamine/zinc pyrithione shampoo in scalp seborrheic dermatitis treatment. Eur J Dermatol. 2006;16:558–64.

Viode C, Lejeune O, Villeneuve C, et al. Evidence of cathepsin S, PAR2 and histamine interest in pruritus aspect of clinical dandruff/seborrheic dermatitis evaluation-poster n° 107. Acta Dermatol Venereol. 2013;93:624.

US Department of Health and Human Services FDA. Innovation or stagnation? Challenge and opportunity on the critical path to new medical products. 2004; http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Last Accessed 1 June 2013.