Myfortic® versus Neoral® as long-term treatment in patients with severe atopic dermatitis: a randomised-controlled trial

Completed

• Conditions: Atopic dermatitis; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN70446233
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged from 18 years
2. Atopic dermatitis according to the criteria of Hanifin and Rajka
3. Insufficient response to topical treatment alone
4. The physician estimates that treatment with oral immunosuppressive agents is indicated

Exclusion Criteria

1. Oral immunosuppressive treatment in the last 6 weeks
2. Concomitant ultraviolet (UV) therapy
3. Patients with any known hypersensitivity to cyclosporine (Neoral®) or mycophenolic acid (myfortic®) or other components of the formulation (e.g. lactose)
4. Patients with thrombocytopenia (less than 75000/mm^3), with an absolute neutrophil count of less than 1500/mm^3 and/or leukocytopenia (less than 2500/mm^3), and/or haemoglobin less than 60 g/dL prior to enrolment
5. Patients who have received an investigational drug within two weeks prior to screening (i.e. before day 14 of run-in period)
6. Patients with a history of malignancy within the last five years
7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
8. Presence of clinically significant infection requiring continued therapy, severe diarrhoea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study
9. Known positive human immunodeficiency virus (HIV)
10. Evidence of drug and/or alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical severity score (Local Leverity Score [LSS])

Secondary Outcome Measures

Name	Time	Method
1. Physician Global Assessment Score (PGA)<br>2. Serum levels of thymus and activation and regulated chemokine (TARC)<br>3. Itch (Visual Analogue Score [VAS])<br>4. Amount of topical steroids that is used<br>5. Quality of life, measured with the Dermatology Life Quality Index (DLQI) of Finlay