Reduction of adverse effects by systemic antihistamines during therapy with fumarates in severe chronic plaque psoriasis

Completed

• Conditions: Psoriasis; Skin and Connective Tissue Diseases; Skin diseases

• Registration Number: ISRCTN12758639
• Lead Sponsor: Erasmus Medical Center (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PASI-score

Secondary Outcome Measures

Name	Time	Method
Skin-biopsies