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OpenTrials
Completed

NCT Number: NCT01789619

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Extended release tacrolimus (Advagraf®)

Drug

Primary outcomes

  1. Change in Scoring Atopic Dermatitis (SCORAD)

    Time frame: Every 4 weeks up to one year

    Clinical eczema scores

Secondary outcomes

  1. Change in Patient-Oriented Eczema Measure (POEM)

    Time frame: Every 4 weeks up to one year

    Self administered eczema score

  2. Change in Thymus and Activation-Regulated Chemokine in serum (TARC)

    Time frame: Every 4 weeks up to one year

    Biomarker atopic dermatitis

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2013
Registry last updated
May 29, 2015

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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