Urticaria Facticia Treatment With Omalizumab (UFO)
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Urticaria is a very frequent skin condition characterized by transient wheal and flare type
skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients
are thought to suffer from persisting urticaria symptoms, which either occur spontaneously,
i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli
such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia
(also known as dermographic urticaria and symptomatic dermographism) is characterized by
whealing and itching following a minor stroking pressure, rubbing or scratching of the skin.
The majority of patients with urticaria factitia benefits from treatment with nonsedating
antihistamines. Some patients, however, do not achieve adequate symptom control even with
updosing of antihistamines and may suffer from substantial quality of life impairment . Since
even very minor stroking of the skin can lead to the development of wheals and severe
itching, these patients are for example limited in their choice of clothing and are impaired
in their social interaction and partnership.
In all patients with a history of wheals after stroking of the skin, a provocation test
should be performed. This can be done by stroking of the skin lightly with a smooth blunt
object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built
instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the
smooth blunt object should be held perpendicular to the skin and should be used to apply a
light stroking pressure to the skin of the upper back or volar forearm. The reaction is
considered positive in patients who show a weal response and report pruritus at the site of
provocation.
Patients with a positive test reaction should be evaluated for individual pressure
thresholds. For this purpose a provocation device (FricTest) has been developed that allows
for reproducible and standardized threshold testing. Threshold testing enables physicians to
assess disease severity and treatment response more precisely.