None listed
Conditions
Interventions
10 patients in total with atopic dermatitis are to be included in the study. The inclusion takes place after the physician has indicated that treatment with oral immunosuppressive drugs is necessary.
Sponsors
UMC Utrecht, department of Dermatology:
Dr. M.S. de Bruin-Weller
Dr. E.F. Knol
Prof. dr. C.A.F.M. Bruijnzeel-Koomen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age from 18 years; 2. Atopic dermatitis according to the criteria of Hanifin and Rajka; 3. Insufficient respons to topical therapy alone; 4. The physician estimates that treatment with oral immunosuppressiva agents is indicated.
Exclusion criteria
Exclusion criteria: 1. Patients with any known hypersensitivity to mycofenolic acid or other components of the formulation; 2. Oral immunosuppressive treatment in the last 6 weeks; 3. Concomittant UV therapy or UV therapy in the last two months; 4. Contact with UV on the laesional skin for the last two months; 5. Patients with thrombocytopenia (<75.000/mm3), with an absolute neutrophil count <1.500/mm3 and/or leukocytopenia (<2.500/mm3) and/or hemoglobin <6,0g/dl priot to enrollment; 6. Patients who have received an investigational drug within two weeks prior to screening; 7. Patients with a history of malignancy within the last five years; 8. 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; 9. Patients with an immunologic disorder (like RA, SLE or M. Sjögren) or a preexistent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema); 10. Presence of clinically significant infection requiring continued therapy, severe diarrhea or uncontrolled diabetes mellitus that would interfere with the appropiate conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the percentage in repair of cyclobutane pyrimidine dimers (CPD's) before and after treatment with Myfortic is the primary study outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes are the atopic state before and after treatment with Myfortic®. | — |
Contacts
Public ContactM.S. Bruin-Weller, de
University Medical Center Utrecht (UMCU), Department of Dermatology, HPN G02.124 P.O. Box 85500
Outcome results
None listed