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Sponsors and Collaborators: |
Istituti Fisioterapici Ospitalieri University of Bologna |
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Information provided by: | Istituti Fisioterapici Ospitalieri |
ClinicalTrials.gov Identifier: | NCT00723437 |
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.
Condition | Intervention | Phase |
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Psoriasis |
Drug: acitretin |
Phase IV |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin |
Enrollment: | 36 |
Study Start Date: | January 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Department of Dermatology University of Bologna | |
bologna, Italy, 40138 |
Principal Investigator: | Antonella Tosti, MD | University of Bologna |
Responsible Party: | University of Bologna ( Antonella Tosti MD ) |
Study ID Numbers: | NAIL1 |
Study First Received: | July 24, 2008 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00723437 History of Changes |
Health Authority: | Italy: Ethics Committee |
nail, psoriasis, NAPSI,acitretin |
Keratolytic Agents Skin Diseases Psoriasis Acitretin Skin Diseases, Papulosquamous |
Keratolytic Agents Skin Diseases Psoriasis Therapeutic Uses |
Dermatologic Agents Acitretin Skin Diseases, Papulosquamous Pharmacologic Actions |