Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

Phase 2

Completed

• Conditions: Nail Psoriasis
• Interventions: Drug: Experimental Tazarotene Gel; Drug: Placebo

• Registration Number: NCT02235480
• Lead Sponsor: Almirall, S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-31
• Primary Completion: 2014-05
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tazarotene Gel	Experimental Tazarotene Gel	once daily
Placebo Gel	Placebo	once daily

Primary Outcome Measures

Name	Time	Method
% reduction in the Nail Psoriasis Severity Index ( NAPSI )	Day85

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Day 85

Trial Locations

Locations (4)

Investigational site 3; 🇩🇪 Berlin, Germany

Investigational site 4; 🇩🇪 Berlin, Germany

Investigational 2; 🇩🇪 Hamburg, Germany

Investigational site 1; 🇩🇪 Hamburg, Germany