Condition category
Skin and Connective Tissue Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes