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

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Extended release tacrolimus (Advagraf®)

• Registration Number: NCT01789619
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extended release tacrolimus (Advagraf®)	Extended release tacrolimus (Advagraf®)	-

Primary Outcome Measures

Name	Time	Method
Change in Scoring Atopic Dermatitis (SCORAD)	Every 4 weeks up to one year	Clinical eczema scores

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands