Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison

The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.

Study Overview

• Status: Completed
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Experimental Tazarotene Gel

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Investigational site 3
  • Berlin, Germany
    • Investigational site 4
  • Hamburg, Germany
    • Investigational 2
  • Hamburg, Germany
    • Investigational site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Key inclusion criteria:
• Mild to moderate nail psoriasis on at least one fingernail

Exclusion Criteria:

Key exclusion criteria:

• any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
• history of hypersensitivity to retinoids or to other components of the trial medication
• topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
• systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
• intralesional steroid injection before the treatment phase of the trial
• phototherapy before the treatment phase of the trial;
• any chronic infection or condition capable of interfering with the conduct of the trial;
• evidence of drug or alcohol abuse;
• symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;
• participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
• pregnancy or nursing;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tazarotene Gel; once daily	Drug: Experimental Tazarotene Gel
Placebo Comparator: Placebo Gel; once daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% reduction in the Nail Psoriasis Severity Index ( NAPSI )	Day85

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Day 85

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Tazarotene
• Other Study ID Numbers: H 573 000 1307; 2013-004519-28 (EudraCT Number)