Contact information
Type
Scientific
Primary contact
Dr I Haeck
ORCID ID
Contact details
University Medical Center Utrecht
Department of Dermatology
HPN G02.124
Postbus 85500
Utrecht
-
Netherlands
+31 (0)30 250 7388
I.Haeck@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR329
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Atopic dermatitis
Intervention
After initial treatment of 6 weeks with Neoral® 5 mg/kg for all patients, there is a randomisation in two groups. One group is treated with Neoral® 3 mg/kg and the other group with Myfortic® 1440 mg.
Intervention type
Drug
Phase
Not Specified
Drug names
Myfortic®, Neoral®
Primary outcome measure
Clinical severity score (Local Leverity Score [LSS])
Secondary outcome measures
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
Overall trial start date
01/09/2005
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
-
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Novartis Pharma B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list