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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293917

Enrollment

658

Registered

2006-02-20

Start date

2006-01-31

Completion date

2007-08-31

Last updated

2008-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Treatment Outcome, Tacrolimus, Safety, Psoriasis

Brief summary

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

Detailed description

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.

Interventions

DRUGTacrolimus Cream

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety	12 months

Secondary

Measure	Time frame
Efficacy	12 months

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026