Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02169115
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2014-06-12
Brief Title:
Urticaria Facticia Treatment With Omalizumab UFO
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Double-blind Placebo-controlled 12-week Parallel-group Study With a 6 Weeks Follow up Period to Demonstrate Efficacy and Safety of Subcutaneous Omalizumab in Patients With Urticaria Factitia Refractory to Standard Treatment
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UFO
Brief 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 ie 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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-005615-87 | EUDRACT_NUMBER | None | None |