Efficacy and safety of Aethoxysklerol compared to Sodium Tetradecyl Sulfate and Isotonic Saline (placebo) for the treatment of reticular veins and spider veins including subgroup to investigate the plasma concentrations of polidocanol

• Conditions: Patients suffering from varicose veins (spider veins or reticular veins in the legs) should be treated with a sclerosing agent.; MedDRA version: 8.1Level: LLTClassification code 10047001Term: Varicose veins

• Registration Number: EUCTR2006-004565-33-DE
• Lead Sponsor: Chemische Fabrik Kreussler & Co.GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified