None listed
Conditions
Interventions
After initial treatment of 6 weeks with Neoral® 5 mg/kg for all patients, there is a randomization in two groups. One group is treated with Neoral® 3 mg/kg and the other group with Myfortic® 1440 mg.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 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
Exclusion criteria: 1. Oral immunosuppressive treatment in the last 6 weeks; 2. Concomitant 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 (< 75.000/mm3), with an absolute neutrophil count of < 1.500/mm3 and/or leukocytopenia (< 2.500/mm3), and/or haemoglobin < 6.0 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 diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study; 9. Known positive HIV; 10. Evidence of drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical severity score: LSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physician global assessment score (PGA); 2. Serum levels of thymus and activation and regulated chemokine (TARC); 3. Itch (Visual analogue score, VAS); 4. Amount of topical steroids that is used; 5. Quality of life, measured with the Dermatology Life Quality Index (DLQI) of Finlay. | — |
Contacts
Public ContactI. Haeck
University Medical Center Utrecht (UMCU), Department of Dermatology, HPN G02.124, P.O. Box 85500
Outcome results
None listed