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Completed

NCT Number: NCT00293917

A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Winnipeg, Manitoba, Canada

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About this study

A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of plaque psoriasis

Exclusion criteria

  • Skin disorder other than plaque psoriasis in the areas to be treated.
  • Disease on only scalp

Treatment and study plan

Tacrolimus cream

Drug

Primary outcomes

  1. Safety

    Time frame: 12 months

Secondary outcomes

  1. Efficacy

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 20, 2006
Registry last updated
Feb 13, 2008

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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