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NCT01789619 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01789619
Other study ID #
Secondary ID
Status Completed
Phase Phase 2
First received February 6, 2013
Last updated May 28, 2015
Start date October 2012
Est. completion date January 2014

Study information
Verified date May 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Extended release tacrolimus (Advagraf®)

Locations
Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Scoring Atopic Dermatitis (SCORAD) Clinical eczema scores Every 4 weeks up to one year No
Secondary Change in Patient-Oriented Eczema Measure (POEM) Self administered eczema score Every 4 weeks up to one year No
Secondary Change in Thymus and Activation-Regulated Chemokine in serum (TARC) Biomarker atopic dermatitis Every 4 weeks up to one year No
See also
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