Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

Study Overview
=================
Brief Summary
-----------------
Objective: Efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively. Evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis. Design: Open-study on thirty-six patients with moderate to severe nail psoriasis treated with acitretin. Participants: Patients included 27 men and 9 women (mean age 41) with nail psoriasis. Intervention: Therapy consisted of acitretin 0.2 to 0.3 mg/Kg/day for 6 months. Main Outcome Measure(s): Clinical evaluation, NAPSI and modified NAPSI scores before therapy, every 2 months during therapy and 6 months after treatment.

Detailed Description
-----------------
The Nail Psoriasis Severity Index (NAPSI) has been designed and successfully implemented to grade severity of psoriatic nail disease. Moreover, the utilization of the NAPSI score and a modified version of this severity index score as an instrument to monitor response to therapy has been recently documented in the medical literature .This open study involves thirty-six patients with moderate to severe nail psoriasis treated with low-dose acitretin from January 2005 to January 2007.Acitretin was given at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months. Laboratory investigations and clinical evaluation, which included photographic record and scoring of NAPSI and modified NAPSI, were performed every 2 months. Investigator evaluation was performed using a 0 (no improvement) to 3 (cleared or almost cleared) score Treatment satisfaction by patients and tolerability were assessed at each visit. All patients were followed for at least 6 months after the end of treatment.

Official Title
-----------------
Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: acitretin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with moderate to severe nail psoriasis Exclusion Criteria: premenopausal women patients with hepatic, renal or metabolic diseases patients with skin or symptomatic arthropathic psoriasis previous systemic treatment for nail psoriasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acitretin|Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate clinical improvement with % reduction in the NAPSI Score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nail, psoriasis, NAPSI,acitretin