Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

July 25, 2008 updated by: Istituti Fisioterapici Ospitalieri

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Department of Dermatology University of Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Fisioterapici Ospitalieri

Collaborators

University of Bologna

Investigators

  • Principal Investigator: Antonella Tosti, MD, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 28, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2008

Last Update Submitted That Met QC Criteria

July 25, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAIL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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