Myfortic® versus Neoral® as long-term treatment in patients with severe atopic dermatitis: a randomised-controlled trial
| ISRCTN | ISRCTN70446233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70446233 |
| Secondary identifying numbers | NTR329 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr I Haeck
Scientific
Scientific
University Medical Center Utrecht
Department of Dermatology, HPN G02.124
Postbus 85500
Utrecht
-
Netherlands
| Phone | +31 (0)30 250 7388 |
|---|---|
| I.Haeck@umcutrecht.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2005 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
-
Netherlands
-
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Industry
Novartis Pharma B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
