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

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ClinicalTrials.gov Identifier: NCT01789619
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dr M.S. de Bruin-Weller, UMC Utrecht

Brief Summary:
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.

Condition or disease Intervention/treatment
Atopic Dermatitis Drug: Extended release tacrolimus (Advagraf®)

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

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



Primary Outcome Measures :
  1. Change in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Every 4 weeks up to one year ]
    Clinical eczema scores


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789619


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: C AFM Bruijnzeel-Koomen, MD, PhD UMC Utrecht

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Responsible Party: Dr M.S. de Bruin-Weller, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01789619     History of Changes
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action