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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Treatments: Tacrolimus

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