Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

This study has been completed.
Sponsor:
Collaborator:
University of Bologna
Information provided by:
Istituti Fisioterapici Ospitalieri
ClinicalTrials.gov Identifier:
NCT00723437
First received: July 24, 2008
Last updated: July 25, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: acitretin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin

Resource links provided by NLM:


Further study details as provided by Istituti Fisioterapici Ospitalieri:

Primary Outcome Measures:
  • correlate clinical improvement with % reduction in the NAPSI Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2005
Study Completion Date: July 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: acitretin
    Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.
    Other Name: Neotigason
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723437

Locations
Italy
Department of Dermatology University of Bologna
Bologna, Italy, 40138
Sponsors and Collaborators
Istituti Fisioterapici Ospitalieri
University of Bologna
Investigators
Principal Investigator: Antonella Tosti, MD University of Bologna
  More Information