Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

NCT ID: NCT00723437

Last Updated: 2008-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-07-31

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.

Conditions

Psoriasis

Keywords

nail, psoriasis, NAPSI,acitretin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

acitretin

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

Intervention Type: DRUG

Other Intervention Names

Neotigason

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: collaborator

Istituti Fisioterapici Ospitalieri

OTHER

Sponsor Role: lead

Responsible Party

University of Bologna

Principal Investigators

Antonella Tosti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

Department of Dermatology University of Bologna

Bologna, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 18083272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12894066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15009317 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17216680 (View on PubMed)

Other Identifiers

NAIL1

Identifier Type: -

Identifier Source: org_study_id