Condition category
Skin and Connective Tissue Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
18/09/2008
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 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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Dermatology and Venereology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes