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Completed

NCT Number: NCT02235480

Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site 3, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Experimental Tazarotene Gel

Drug

Placebo

Drug

Primary outcomes

  1. % reduction in the Nail Psoriasis Severity Index ( NAPSI )

    Time frame: Day85

Secondary outcomes

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

    Time frame: Day 85

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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