Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

NCT ID: NCT00523952

Last Updated: 2014-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-09-30

Brief Summary

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Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

Detailed Description

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The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

tacrolimus ointment

Intervention Type DRUG

tacrolimus, single arm, 0.1 ointment

Interventions

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tacrolimus ointment

tacrolimus, single arm, 0.1 ointment

Intervention Type DRUG

Other Intervention Names

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Protopic FK506 Ointment

Eligibility Criteria

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Inclusion Criteria

* Male or female, any ethnic group, age ≥16
* Moderate to severe atopic dermatitis
* Has given informed consent

Exclusion Criteria

* Erythroderma
* Pregnant or breast-feeding
* Skin infection on the affected area
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma GmbH

Locations

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Brno, , Czechia

Site Status

Hradec Králové, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

Site Status

Ústí nad Labem, , Czechia

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Bialystok, , Poland

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Częstochowa, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Countries

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Czechia Hungary Poland

Other Identifiers

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FG-506-06-CEE-01

Identifier Type: -

Identifier Source: org_study_id

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