title: Immunomodulating treatment with low dose interleukin-4, interleukin-10 and interleukin-11 in psoriasis vulgaris.
abstract: Psoriasis is a chronic inflammatory skin disease affecting approximately 2-3 percent of the world population; it is characterised by hyperproliferation and hyperplasia of the superficial layers of the epidermis. Inappropriate signals released by the immune system determine an altered keratinocyte differentiation, resulting in the formation of desquamating, thickened, inflamed and erythematous plaques. The aim of this investigation was to study the pharmacological activity and safety of three low dose cytokines, Guna-Interleukin 4, Guna-Interleukin 10 and Guna-Interleukin 11 at the concentration of 10 fg/ml in patients affected by moderate to slight psoriasis vulgaris. The multicenter, double-blind, randomized, placebo-controlled clinical trial involved 48 patients who were enrolled and followed up according to a 8-month experimental project. All patients received, according to a cross-over model, either the experimental treatment or placebo, alternatively. Globally, in the 41 evaluated patients it was observed a PASI significant reduction (Friedman test: p=0.00960). The DLQI too decreased significantly in all subjects compared to baseline (Friedman test: p=0.00007). The safety of the treatment with three low dose cytokines administered simultaneously was proved; no adverse event was reported during the whole trial.
authors.affiliation: Private Practice, Rome, Italy.
authors.forename: M L
authors.initials: ML
authors.lastname: Roberti
authors.affiliation: Sinergheia Medical Center, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Ricottini
authors.affiliation: Private Practice, Latina, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Capponi
authors.affiliation: OSTEMDA, Therapeutic Strategies Empowerment and Advanced Diagnostic Methods Organization, Udine, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Sclauzero
authors.affiliation: Private Practice, Altamura, Bari, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vicenti
authors.affiliation: Dermatological Health Clinic, Aversa, Caserta, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Fiorentini
authors.affiliation: Private Practice, Fino Mornasco, Como, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Savoia
authors.affiliation: Private Practice, Catania, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Scornavacca
authors.affiliation: Private Practice, Turin, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Brazioli
authors.affiliation: Private Practice, Caserta, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Gaio
authors.affiliation: Aurelia Medical Center, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Giannetti
authors.affiliation: Local Health Unit (ASL), Putignano, Bari, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Ignazzi
authors.affiliation: GEA Medica Medical Center, Montebelluna, Treviso, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Meloni
authors.affiliation: Istituto Dermopatico dellImmacolata (IDI), Rome, Italy.
authors.forename: L M
authors.initials: LM
authors.lastname: Chinni
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016753:Interleukin-10 / Q000009:adverse effects / Q000627:therapeutic use*; D017370:Interleukin-11 / Q000009:adverse effects / Q000627:therapeutic use*; D015847:Interleukin-4 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D017370:Interleukin-11; D016753:Interleukin-10; D015847:Interleukin-4