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


- candidate number0
- NTR NumberNTR329
- ISRCTNISRCTN70446233
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR16-sep-2005
- Secondary IDsN/A 
- Public TitleMyfortic® versus Neoral® as long-term treatment in patients with severe atopic dermatitis: a randomized-controlled trial.
- Scientific TitleMyfortic® versus Neoral® as long-term treatment in patients with severe atopic dermatitis: a randomized-controlled trial.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAtopic dermatitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2007
- Target number of participants40
- InterventionsAfter 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.
- Primary outcomeClinical severity score: LSS.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES I. Haeck
- CONTACT for SCIENTIFIC QUERIES I. Haeck
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Dermatology and Allergology
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-okt-2005 - 5-jan-2010


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