Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

May 28, 2015 updated by: Dr M.S. de Bruin-Weller, UMC Utrecht
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

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

  • Netherlands
      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.

Description

Inclusion Criteria:

  • Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.

Exclusion Criteria:

  • Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
  • Preexisting abnormalities in liver function, kidney function or haematological abnormalities
  • History of malignancy within the last 5 years
  • Uncontrolled hypertension
  • Pregnancy or lactation; wish for pregnancy during the treatment period
  • Infections requiring continued therapy
  • Known positivity for HIV
  • Evidence of drug and/or alcohol abuse

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extended release tacrolimus (Advagraf®)
Drug: Extended release tacrolimus (Advagraf®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Scoring Atopic Dermatitis (SCORAD)
Time Frame: Every 4 weeks up to one year
Clinical eczema scores
Every 4 weeks up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Oriented Eczema Measure (POEM)
Time Frame: Every 4 weeks up to one year
Self administered eczema score
Every 4 weeks up to one year
Change in Thymus and Activation-Regulated Chemokine in serum (TARC)
Time Frame: Every 4 weeks up to one year
Biomarker atopic dermatitis
Every 4 weeks up to one year

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: C AFM Bruijnzeel-Koomen, MD, PhD, UMC Utrecht

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

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.

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