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.
|
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)
Placebo-Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy [Recruiting]
Chronic Achilles tendinopathy is a common disease especially in adults. The golden standard
in treatment has up to now been excentric exercise, but with varying success. A new
hypothesis is that this chronic pain is due to neo vascularisation, and in a pilot study,
sclerosing injections with polidocanol has been successfully used. The aim of our study is
to try the hypothesis and the efficacy of polidocanol as a treatment in a randomised
controlled setting on a larger scale.
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS) [Not yet recruiting]
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) [Recruiting]
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.
Efficacy and Safety Study of Varisolve⢠Polidocanol Endovenous Microfoam (PEM)for the Treatment of Saphenofemoral Junction (SFJ) Incompetence [Not yet recruiting]
To evaluate the efficacy and safety of Varisolve™ PEM 0. 5% and 1% compared to Agitated
Saline and compared to Varisolve™ PEM 0. 125% in patients with SFJ incompetence due to reflux
of the great saphenous vein (GSV) or major accessory veins, with venous disease manifested
by both symptoms and visible varicosities
Endovenous Ablation With and Without Varisolve PEM Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities [Recruiting]
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 two different doses of an investigational drug, Varisolve™ Polidocanol
Endovenous Microfoam (Varisolve™ PEM) compared to placebo (inactive solution) when used
following an approved heat treatment in subjects with varicose veins.
The main portion of the vein that is causing the varicose veins will be treated with one of
two FDA-approved heat treatments which are applied inside the vein. Heat treatment is
generally limited to veins above the knee. After the heat treatment is completed, during
the same treatment sessions, visible varicose veins above or below the knee will be treated
with either 0. 5% or 1. 0% of study drug or a placebo solution which will be injected into the
visible veins.
Patients will rate the appearance of the treated leg before and after treatment by using a
specially designed set of questions. Pictures will be taken of each patient's leg before
and after treatment, and these photographs will be sent to an independent group of
phyisicians who will rate the appearance of each leg before and after treatement using a set
of specially designed questions which differ from those used by patients.
The sponsor of the study expects that patients having legs treated with heat treatment plus
0. 5% or 1. 0% of Varisolve will rate the amount of improvement in their legs' appearance to
be greater than those patients having legs treateed with heat treatment plus a placebo
injection. The sponsor expects that the independent photograph reviewers will see a similar
pattern of improvement in the appearance of the treated legs.
|
