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Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723437
First Posted: July 28, 2008
Last Update Posted: July 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Bologna
Information provided by:
Istituti Fisioterapici Ospitalieri
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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