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Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723437
Enrollment
36
Registered
2008-07-28
Start date
2005-01-31
Completion date
2008-07-31
Last updated
2008-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

nail, psoriasis, NAPSI,acitretin

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.

Interventions

DRUGacitretin

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

Sponsors

University of Bologna
CollaboratorOTHER
Istituti Fisioterapici Ospitalieri
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
correlate clinical improvement with % reduction in the NAPSI Score6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026