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

August 28, 2014 updated by: Astellas Pharma Inc

A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
      • Hradec Kralove, Czech Republic
      • Ostrava, Czech Republic
      • Plzen, Czech Republic
      • Prague, Czech Republic
      • Tabor, Czech Republic
      • Usti nad Labem, Czech Republic
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Györ, Hungary
      • Kecskemet, Hungary
      • Miskolc, Hungary
      • Pecs, Hungary
  • Poland
      • Bialystok, Poland
      • Czestochowa, Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Sopot, Poland
      • Szczecin, Poland
      • Warsaw, Poland
      • Wroclaw, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: tacrolimus ointment
tacrolimus, single arm, 0.1 ointment
Other Names:
  • Protopic
  • FK506 Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician's evaluation of clinical response
Time Frame: 12 weeks
12 weeks
Patient's assessment of global response
Time Frame: 12 weeks
12 weeks
Affected body surface area
Time Frame: 12 weeks
12 weeks
Quality of Life at Baseline/Day 1 and Week 12/End of study
Time Frame: 12 weeks
12 weeks
Changes of mEASI
Time Frame: 12 weeks
12 weeks
Incidence of adverse events during the study, including all clinically significant laboratory values
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-06-CEE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dermatitis, Atopic

Clinical Trials on tacrolimus ointment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe