ASCLERA SUMMARY
11 DESCRIPTION Asclerais a sterile, nonpyrogenic, and colorless to faintly greenish-yellowsolution of polidocanol for intravenous use as a sclerosing agent. The active ingredient, polidocanol is a non-ionic detergent, consisting oftwo components, a polar hydrophillic (dodecyl alcohol) and an apolarhydrophobic (polyethylene oxide) chain.
AscleraTM (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins less than or equal to 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.
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NEWS HIGHLIGHTS
Published Studies Related to Asclera (Polidocanol)
Treatment of reticular and telangiectatic leg veins: double-blind, prospective
comparative trial of polidocanol and hypertonic saline. [2012] dermatologic surgery practices... CONCLUSION: Both agents provided effective treatment, but HS caused 2.35 times as
A randomized trial comparing 2 doses of polidocanol sclerotherapy for hydrocele or spermatocele. [2011.10] PURPOSE: Polidocanol sclerotherapy for hydrocele or spermatocele combines high efficiency with low morbidity, but the optimal dose is not known. We compared the efficacy and morbidity of 2 or 4 ml polidocanol sclerotherapy for hydrocele or spermatocele... CONCLUSIONS: Polidocanol sclerotherapy was effective for the treatment of hydrocele or spermatocele in our patients, with 94% satisfactory results after 1 to 4 treatments. A dose of 4 ml was superior to 2 ml, particularly for larger hydroceles/spermatoceles. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Ultrasound-guided sclerotherapy of the great saphenous vein with 1% vs. 3% polidocanol foam: a multicentre double-blind randomised trial with 3-year follow-up. [2010.06] OBJECTIVES: The aim of this study was to compare the efficacy and side effects of ultrasound-guided foam sclerotherapy of the great saphenous vein using 1% and 3% polidocanol foam with a 3-year follow-up. DESIGN: A multicentre prospective double-blind randomised clinical trial comparing the efficacy of 1% vs. 3% polidocanol sclerosant foam... CONCLUSIONS: This is the first randomised clinical trial of ultrasound-guided foam sclerotherapy which is a 3-year follow-up and shows equivalent efficacy of 1% and 3% sclerosant foam. Clinical trial registration number: 2006-07-05. Copyright (c) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). [2010.06] OBJECTIVES: To assess the efficacy and safety of polidocanol (POL) in comparison to sodium tetradecyl sulphate (STS) and isotonic saline (placebo) for sclerotherapy of telangiectases or reticular veins by means of standardized digital imaging system, independent medical observers and detailed monitoring... CONCLUSION: Sclerotherapy of telangiectases and reticular veins with detergent-like sclerosants such as polidocanol (POL) or sodium tetradecyl sulphate (STS) is a well-established technique. However, evidence from clinical trials comparing these substances with a non-active solution is sparse and does not live up to expectations of modern clinical trial concepts necessary for authorisation purposes. The presented multicentre EASI study fulfils these requirements and clearly demonstrates that Sclerotherapy of C1 veins with POL is highly effective and deserves the adjunct 'gold standard'.
Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). [2010] OBJECTIVES: To assess the efficacy and safety of polidocanol (POL) in comparison to sodium tetradecyl sulphate (STS) and isotonic saline (placebo) for sclerotherapy of telangiectases or reticular veins by means of standardized digital imaging system, independent medical observers and detailed monitoring... CONCLUSION: Sclerotherapy of telangiectases and reticular veins with detergent-like sclerosants such as polidocanol (POL) or sodium tetradecyl sulphate (STS) is a well-established technique. However, evidence from clinical trials comparing these substances with a non-active solution is sparse and does not live up to expectations of modern clinical trial concepts necessary for authorisation purposes. The presented multicentre EASI study fulfils these requirements and clearly demonstrates that Sclerotherapy of C1 veins with POL is highly effective and deserves the adjunct 'gold standard'.
Clinical Trials Related to Asclera (Polidocanol)
The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy [Completed]
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard
in treatment has up to now been excentric exercises but with varying success. A new
hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study
sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study
the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger
scale.
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence [Completed]
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
may cause discomfort. In this study, patients with varicose veins in the legs will be
participating. The purpose of this research study is to evaluate the safety and
effectiveness of three different concentrations of an investigational drug, polidocanol
injectable foam compared to vehicle (inactive solution) in treating the symptoms and
appearance of varicose veins.
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence [Completed]
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
may cause discomfort. In this study, patients with varicose veins in the legs will be
participating. The purpose of this research study is to evaluate the safety and
effectiveness of three different concentrations of an investigational drug, Polidocanol
Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms
and appearance of varicose veins.
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins [Recruiting]
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
hypertonic glucose of sclerotherapy in lower limbsī reticular veins. It will be included
only adult women with reticular veins on the side of the thighs and mild venous
insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) [Completed]
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
may cause discomfort. In this study, patients with varicose veins in the legs will be
participating. The purpose of this research study is to evaluate the pharmacokinetic profile
of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM),
an investigational treatment for varicose veins.
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Page last updated: 2013-02-10
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