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Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

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ClinicalTrials.gov Identifier: NCT00723437
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : July 28, 2008
Sponsor:
Collaborator:
University of Bologna
Information provided by:
Istituti Fisioterapici Ospitalieri

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: acitretin Phase 4

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  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Acitretin


Intervention Details:
  • Drug: acitretin
    Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.
    Other Name: Neotigason


Primary Outcome Measures :
  1. correlate clinical improvement with % reduction in the NAPSI Score [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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