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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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