Among physical urticaria patients about 20-30% have urticaria factitia. The pathomechanism of urticaria factitia is not clear. Antihistamines are used to treat the condition, and this is in accordance with the most recent European Guideline. However, the efficacy of antihistamine therapy in urticaria factitia is not sufficiently proven by clinical studies.Cinnarizine and iprazochrome therapy is an effective well tolerated therapy in urticaria factitia.
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Stugeron
CAS Number: 298-57-7
Other descriptive name: CINNARIZINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
Department of Dermatology and Allergology, University of Szeged
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We enroll into the study forty urticaria factitia patients between the ages of 16 and 64 years old. These patients are to be treated with the diagnosis of urticaria factitia in Szeged, at the Department of Dermatology and Allergology Clinic. We will diagnose the disease using a dermographometer. Patients involved in the study will not suffer from major medical illnesses. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be pregnancy, lactation, other types of mechanical and physical urticaria and history of malignancy within 5 years of occurrence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): This study lasts for a period of 6 month, and we plan four visits during the study. We divide the patients into two groups based on chance (A Group, B Group). A Group: patients will be receiving 10 mg Aerius (desloratadine) tablets twice a day B Group: patients will be receiving 25 mg Stugeron (cinnarizine) tablets three times daily and 2,5 mg Divascan (iprazochrome) tablets twice a day I. Visit: Screening and enrollment of the patients Group classification (A or B Group) Initiation of treatment Completing Quality of life questionnaire Determining the severity index (Breneman index) II.Visit: 4 weeks after starting medical treatment Skin symptoms of urticaria factitia measurement Therapy efficiency measurement with dermographometer Completing Quality of life questionnaire Determining the severity index (Breneman index) Doctor and patient assess the effectiveness of therapy Description of adverse effects ;Timepoint(s) of evaluation of this end point: III. Visit: 12 weeks after starting medical treatment Skin symptoms of urticaria factitia measurement Therapy efficiency measurement with dermographometer Completing Quality of life questionnaire Determining the severity index (Breneman index) Doctor and patient assess the effectiveness of therapy Description of adverse effects ;Main Objective: Determining the efficacy of the combined cinnarizine and iprazochrome therapy for the treatment of urticaria factitia disease. We enroll into the study forty urticaria factitia patients between the ages of 16 and 64 years old. These patients are to be treated with the diagnosis of urticaria factitia in Szeged, at the Department of Dermatology and Allergology Clinic. We will diagnose the disease using a dermographometer. This study lasts for a period of 6 month, and we plan four visits during the study. We divide the patients into two groups based on chance (A Group, B Group). A Group: patients will be receiving 10 mg Aerius (desloratadine) tablets twic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Skin symptoms of urticaria factitia measurement Therapy efficiency measurement with dermographometer Completing Quality of life questionnaire Determining the severity index (Breneman index) Doctor and patient assess the effectiveness of therapy Description of adverse effects ;Timepoint(s) of evaluation of this end point: IV. Visits: 6 month after starting medical treatment Skin symptoms of urticaria factitia measurement Therapy efficiency measurement with dermographometer Completing Quality of life questionnaire Determining the severity index (Breneman index) Doctor and patient assess the effectiveness of therapy Description of adverse effects | — |
Countries
Hungary
Contacts
Public ContactZsuzsanna Bata-Csörgo
Department of Dermatology and Allergology, University of Szeged
Outcome results
None listed