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Reduction of adverse effects by systemic antihistamines in drug therapy with fumarates in severe chronic plaque psoriasis: a doubleblind, randomized, placebo controlled clinical trial

Reduction of adverse effects by systemic antihistamines in drug therapy with fumarates in severe chronic plaque psoriasis: a doubleblind, randomized, placebo controlled clinical trial - Reduction of adverse effects of fumarates with antihistamines.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37148
Enrollment
50
Registered
2009-08-11
Start date
2009-11-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fumarates side-effects

Interventions

psoriasis vulgaris

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1)Patients with known severe psoriasis of the chronic plaque type 2)PASI >= 10 3)Age >= 18 years 4)Signed informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To attempt to decrease the side effects in patients by using fumarates in combination with antihistamines (Cetirizine).

Secondary

MeasureTime frame
We will attempt to show that antihistamines can also support fumarate therapy with an antipsoriatic effect through immunomodulation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)