Contact information
Type
Scientific
Primary contact
Dr S Fallah-Arani
ORCID ID
Contact details
Erasmus Medical Center
Dermatology Department
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4639222
s.fallaharani@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR744
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Psoriasis
Intervention
Randomisation in two groups. One patient group will receive fumarate therapy combined with levocetirizine. The other patient group will receive fumarate therapy combined with a placebo instead of levocetirizine.
Intervention type
Drug
Phase
Not Specified
Drug names
Fumarate therapy, levocetirizine
Primary outcome measures
PASI-score
Secondary outcome measures
Skin-biopsies
Overall trial start date
01/09/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with known severe psoriasis of the chronic plaque type
2. Psoriasis Area and Severity Index (PASI) more than ten
3. Age more than 18 years
4. Psoriasis therapies cannot be administered starting from 28 days before baseline visit until discontinuation of the study medications at the end of the study
5. All forms of ultraviolet light therapy are prohibited during the study through week 12, such as Psoralen Ultraviolet A therapy (PUVA) and Ultraviolet B (UVB) (including narrow band UVB and excimer laser). PUVA is prohibited starting from 28 days before the baseline and UVB is prohibited starting from 14 days before baseline
6. All forms of topical psoriasis therapies cannot be administered from 14 days before baseline until discontinuation of the study medications through week 12
7. Investigational or biological drugs are not permitted from 28 days prior to screening visit until discontinuation of the study medication at the end of study
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Pregnancy and breast-feeding
2. Patients with prostate hyperplasia, glaucoma, stomach ulcer
3. Patients with liver diseases
4. Patients with kidney diseases
5. Patients with blood test deviations
6. Patients with gastro-intestinal diseases
7. Patients with a history of malignancies
8. Presence of clinically significant renal and hepatic laboratory values (i.e., male patients with serum creatinine more than or equal to 133 umol/L; female patients with serum creatinine more than or equal to 124 umol/L; Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], total bilirubin, Gamma-Glutamyl Transferase [GGT], or Alkaline Phosphatase more than 2.5 times the upper limit of the reference range)
9. Serum lipase impairments (total cholesterol more than 6.5 mmol/l, Low Density Lipoprotein [LDL]-cholesterol less than 2 mmol/l, triglyceride more than 3 mmol/l).
10. Haemoglobin parameters must satisfy the following criteria:
a. haemoglobin less than 7.5 mmol/l
b. leukocytes more than 3.50 x 10^9/l and less than 10 x 10^9/l
c. lymphocytes more than 15% and less than 50% of the total white cell count
Recruitment start date
01/09/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
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