Patients suffering from varicose veins (spider veins or reticular veins in the legs) should be treated with a sclerosing agent. MedDRA version: 8.1 Level: LLT Classification code 10047001 Term: Varicose veins
Conditions
Interventions
Trade Name: Sotradecol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SODIUM TETRADECYL SULFATE
CAS Number: 139888
Current Sponsor code: Sotradecol
Concentration unit: % percent
Conc
Sponsors
Chemische Fabrik Kreussler & Co.GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male / female 2. Age between 18 and 70 years 3. C1 veins (see definition in Section 3.2) 4. Willing and able to provide written informed consent to a participation in the study after having been informed by the investigator about the aim, course and possible risks of the study 5. For females of childbearing potential: must be willing and able to use reliable contraceptive methods throughout the study. Reliable methods for women are hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with C2-C6 venous insufficiency (which could influence the treatment success of C1 veins in this study) 2. Patients with CEAP-classifications: Es und Ec, AD, PO 3. Patients who have already undergone sclerotherapy, laser treatment and surgery during the last twelve weeks of the ipsilateral leg or during the last four weeks of the contralateral leg 4. Acute superficial or deep vein thrombosis 5. History of major superficial thrombosis 6. Patients with positive result for one of the following thrombophilia indicators: Activated Protein C resistance, increased Factor VIII activity, Antithrombin III deficiency, Protein C deficiency, Protein S deficiency, Prothrombin 20210 gene mutation, and Antiphospholipid syndrome as determined by analyzing blood samples taken on day 0 7. History or evidence of previous deep vein thrombosis 8. Patients with all of the following risk factors of thrombosis: - taking hormonal contraceptives or receiving hormone replacement therapy and - adiposity (body mass index greater than 30) and - smoking 9. Patients with other factors implicating a risk of thrombosis (e.g. recent long-distance flight) as judged by investigator 10. Known coagulopathy 11. Patients with known hereditary thrombophilia 12. Major leg edema (if it cannot be influenced by compression therapy) 13. Inflammatory skin disease in the area of treatment 14. Arterial occlusive disease (Fontaine Stage II or more) 15. Clinically relevant abnormalities in the 12-lead electrocardiogram (ECG). 16. Known hypersensitivity to polidocanol (macrogol lauryl ether, lauromacrogol 400) or any of the other ingredients of Aethoxysklerolâ 17. Known hypersensitivity to Sodium Tetradecyl Sulfate or any of the other ingredients of Sotradecol® 18. Known pronounced allergic disposition 19. Acute severe systemic disease or poor general health 20. Severe generalized infection 21. Acute febrile states 22. Reduced mobility 23. Bronchial asthma or known strong predisposition to allergies 24. Symptoms of microangiopathy or neuropathy 25. Pregnant women 26. Lactating women 27. Antipathy against the treatment procedures, aftercare and the follow-up 28. Any participation in another clinical study within 4 weeks (30 days) prior to enrolment in this study. 29. Known history of HIV 30. Known history of hepatitis B or C. 31. History or acute state of alcoholism (5% ethanol content in the study medication) or substance abuse. 32. Regular use of disulfiram (e.g. antibuse) or similar medication. 33. Regular use of anticoagulants (except platelet aggregation inhibitors, i.e. low dose ASS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of Aethoxysklerol in the treatment of C1 veins compared to placebo;Secondary Objective: Secondary objectives: - Efficacy of Aethoxysklerol compared to Sodium Tetradecyl Sulfate.· - Safety of Aethoxysklerolâ · - Patient satisfaction with the treatment Sub-group: - Plasma concentrations of polidocanol after sclerotherapy with 0.5 or 1% Aethoxysklerol in subjects with C1 veins;Primary end point(s): Assessment of the improvement of the veins, according to a 5-grade scale, made 12 weeks (+/- 2 weeks) after the last injection. Comparison between Aethoxysklerol and placebo (isotonic saline). | — |
Countries
Germany
Outcome results
None listed