Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723437
• Other study ID #: NAIL1
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2008
• Last updated: July 25, 2008
• Start date: January 2005
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Istituti Fisioterapici Ospitalieri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Dermatology University of Bologna	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Fisioterapici Ospitalieri	University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Brazzelli V, Martinoli S, Prestinari F, Borroni G. An impressive therapeutic result of nail psoriasis to acitretin. J Eur Acad Dermatol Venereol. 2004 Mar;18(2):229-30. — View Citation

Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9. — View Citation

Rich P, Griffiths CE, Reich K, Nestle FO, Scher RK, Li S, Xu S, Hsu MC, Guzzo C. Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year. J Am Acad Dermatol. 2008 Feb;58(2):224-31. Epub 2007 Dec 20. — View Citation

Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003 Aug;49(2):206-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlate clinical improvement with % reduction in the NAPSI Score		6 months	No