Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis

NCT00723437 | Completed Phase 4

• 1 other identifier: NAIL1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

nail, psoriasis, NAPSI,acitretin

Outcome Measures

Primary Outcomes (1)

• correlate clinical improvement with % reduction in the NAPSI Score

  6 months

Interventions

acitretin DRUG

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

Also known as: Neotigason

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with moderate to severe nail psoriasis

You may not qualify if:

• premenopausal women
• patients with hepatic, renal or metabolic diseases
• patients with skin or symptomatic arthropathic psoriasis
• previous systemic treatment for nail psoriasis

Sponsors & Collaborators

• Istituti Fisioterapici Ospitalieri: lead
• University of Bologna: collaborator

Study Sites (1)

Department of Dermatology University of Bologna

Bologna, 40138, Italy

Location

Related Publications (4)

• 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.

  PMID: 18083272 BACKGROUND

• 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.

  PMID: 12894066 BACKGROUND

• 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.

  PMID: 15009317 BACKGROUND

• 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.

  PMID: 17216680 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Antonella Tosti, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: January 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: July 1, 2008
• Last Updated: July 28, 2008

Record last verified: 2008-07

Locations

IT (1)