Tranexamic Acid and Spontaneous Chronic Urticaria
Tranexamic Acid and Spontaneous Chronic Urticaria
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population
 with a potentially severe impact on quality of life. Most patients respond favorably to
 long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times
 the formal dose, Berlin consensus 2016). These high doses are often accompanied by side
 effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an
 expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been
 shown to be associated with activation of fibrinolysis that correlates with the severity of
 symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer
 levels than patients who responded to antihistamines. Tranexamic acid is a molecule with
 antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to
 treatment with tranexamic acid have been reported. In our department, Investigators also
 noticed the improvement of some of their patients on tranexamic acid. The combination of
 these two treatments appears to be synergistic: action on histamine receptors and control of
 fibrinolysis.

 The investigators propose to evaluate the association of tranexamic acid and levocetirizine
 for the treatment of chronic spontaneous urticaria.
Multicentric controlled randomized crossover study, double-blind To evaluate the efficacy and
 safety of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine
 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks.

 A hierarchical analysis will be implemented in the following order:

 1. Non-inferiority of the combination levocetirizine 10 mg / day + tranexamic acid (TA) 2 g
 / day versus levocetirizine alone 20 mg / day in terms of effectiveness

 2. Superiority of the combination levocetirizine 10 mg / day + tranexamic acid (AT) 2 g /
 day versus levocetirizine alone 20 mg / day in terms of tolerance

 3. Superiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus
 levocetirizine alone 20mg / day in terms of effectiveness Each objective will be tested
 sequentially if and only if the previous objective is validated.
Inclusion Criteria:

 -  Patients with spontaneous chronic urticaria, according to the criteria of the European
 Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European
 Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an
 association of the following symptoms : urticarial eruptions and / or recurrent
 angioedema for at least 6 weeks

 Exclusion Criteria:

 -  Urticaria associated with a specific systemic disease including cutaneous and systemic
 mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with
 cryopyrin

 -  Bradykinin angioedema and isolated angioedema whose origin is not clearly attributable
 to spontaneous chronic urticaria.

 -  Presence of a contraindication to tranexamic acid and to levocetirizine