No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Clinical severity score: LSS.
Secondary outcome
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.
Background summary
N/A
Study objective
N/A
Study design
N/A
Intervention
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.
Department of Dermatology, HPN G02.124,
P.O. Box 85500
I. Haeck
Utrecht
The Netherlands
+31 (0)30 2507388
I.Haeck@umcutrecht.nl
Department of Dermatology, HPN G02.124,
P.O. Box 85500
I. Haeck
Utrecht
The Netherlands
+31 (0)30 2507388
I.Haeck@umcutrecht.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL291 |
| NTR-old | NTR329 |
| Other | : N/A |
| ISRCTN | ISRCTN70446233 |