Clinical trial NCT00723437: Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis
Official title: Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: nail, psoriasis, NAPSI,acitretin
Lead sponsor: Istituti Fisioterapici Ospitalieri
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2008-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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

Primary outcomes:
measure: correlate clinical improvement with % reduction in the NAPSI Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of Dermatology University of Bologna
Study officials:
affiliation: University of Bologna
name: Antonella Tosti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jaad.2007.07.042. Epub 2007 Dec 20.
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. doi: 10.1067/s0190-9622(03)00910-1.
citation: 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. doi: 10.1111/j.1468-3083.2004.00667.x. No abstract available.
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.