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Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

Phase 2CompletedNCT02235480
Almirall, S.A.66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

66

Conditions

Nail Psoriasis

Interventions

Experimental Tazarotene GelDRUG
PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years
Medical Language ↔ Plain English
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;

Locations (4)

Investigational site 3

Berlin, Germany

Investigational site 4

Berlin, Germany

Investigational 2

Hamburg, Germany

Investigational site 1

Hamburg, Germany

Outcomes

Primary Outcomes

% reduction in the Nail Psoriasis Severity Index ( NAPSI )

Time frame: Day85

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: Day 85

Data from ClinicalTrials.gov

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