Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis
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Purpose
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 |
|---|---|---|
|
Psoriasis |
Drug: acitretin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin |
- correlate clinical improvement with % reduction in the NAPSI Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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) |
-
Drug: acitretin
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Italy | |
| Department of Dermatology University of Bologna | |
| Bologna, Italy, 40138 | |
| Principal Investigator: | Antonella Tosti, MD | University of Bologna |
More Information
Publications:
| Responsible Party: | Antonella Tosti MD, University of Bologna |
| ClinicalTrials.gov Identifier: | NCT00723437 History of Changes |
| Other Study ID Numbers: | NAIL1 |
| Study First Received: | July 24, 2008 |
| Last Updated: | July 25, 2008 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Istituti Fisioterapici Ospitalieri:
|
nail, psoriasis, NAPSI,acitretin |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Acitretin |
Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013