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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA
A Journal on Dermatology and Sexually Transmitted Diseases
Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Giornale Italiano di Dermatologia e Venereologia 2001 February;136(1):77-83
Short-term clinical efficacy of the association betamethasone 17-valerate 21-acetate + tretinoina + salicylic acid in outpatients affected with disseminated keratotic plaque psoriasis. A double blinded placebo-controlled multicentric randomized clinical trial
Santoianni P., Di Iorio S. 1, Giannetti A. 2, Manfredi G. 3, Rebora A. 4, Landi G. 5, Fiorentino D. 6, Fileccia P. 7
Università degli Studi «Federico II» - Napoli Dipartimento di Patologia Sistematica Cattedra di Dermatologia
1 Ospedale Civile di Lugo (Ravenna) Divisione di Dermatologia,
2 Università degli Studi - Modena Clinica Dermatologica,
3 Azienda USL Piacenza Divisione Dermatologia
4 Università degli Studi - Genova Clinica Dermatologica
5 Ospedale «Bufalini» - Cesena Divisione Dermatologica e Centro Grandi Ustionati,
6 Ospedale Montejacoviello Santeramo in Colle (Bari) UO di Medicina,
7 IDI Farmaceutici SpA
Background. Topical agents are the treatment of choice for patients that cannot use systemic drugs and for patients with limited extension of the illness. Psoriasis clinical response to topical placebo is high even though available data are not collected with careful methodology. The aim of “evidence-based dermatology” is to apply GCP methods for scientific evaluation of clinical trials. The main goal of the study is to assess short term efficacy (3 weeks) of a drug association in keratotic chronic disseminated plaque psoriasis.
Methods. Study design: a double blinded placebo-controlled multicentric randomized clinical trial. Subjects: 85 outpatients affected with keratotic disseminated plaque psoriasis. Main assessment criteria: PASI score variation. Global efficacy assessment according to the physician and to the patient.
Results. PASI score assessment groups has shown a significative improvement in the active treatment group. After 3 weeks of treatment PASI score reduction was 58.93% in the active treatment group and 43.26% in the placebo group (p=0.016). Global efficacy assessment either by clinicians and by patients was in favour of the association with higher statistical significance than observed with PASI score evaluation (p=0.005 and p=0.018).
Conclusions. The pharmacological association (betamethasone 17-valerate 21-acetate + tretinoine + salicylic acid) was more effective than placebo in short term treatment of chronic disseminated keratotic plaque psoriasis. The systemic and local tolerability were excellent.