Reduction of adverse effects by systemic antihistamines during therapy with fumarates in severe chronic plaque psoriasis
| ISRCTN | ISRCTN12758639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12758639 |
| Secondary identifying numbers | NTR744 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 18/09/2008
- 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 S Fallah-Arani
Scientific
Scientific
Erasmus Medical Center
Dermatology Department
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4639222 |
|---|---|
| s.fallaharani@erasmusmc.nl |
Study information
| Study design | Randomised placebo-controlled clinical 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) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fumarate therapy, levocetirizine |
| Primary outcome measure | PASI-score |
| Secondary outcome measures | Skin-biopsies |
| Overall study start date | 01/09/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Dermatology and Venereology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
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 |
