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OpenTrials
Completed

NCT Number: NCT00723437

Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology University of Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acitretin

Drug

Acitretin at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months.

Other names: Neotigason

Primary outcomes

  1. correlate clinical improvement with % reduction in the NAPSI Score

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Istituti Fisioterapici Ospitalieri

Other

Collaborators

  • University of Bologna

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jul 28, 2008
Registry last updated
Jul 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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