Polidocanol

Generic Name: Polidocanol

Brand Names: Asclera, Varithena

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₆₂O_₁₀

CAS Number: 9002-92-0

Unique Ingredient Identifier: 0AWH8BFG9A

Background: Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. It is marketed under the brand names Asclera and Varithena. The formula for Polidocanol has the structural formula C12H25(OCH2CH2)nOH, a mean extent of polymerization (n) of approximately 9 and a mean molecular weight of approximately 600.

Indication: Polidocanol is a sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity.

Associated Conditions: Pain caused by Teething, Incompetent accessory saphenous veins, Incompetent great saphenous veins, Superficial venous incompetence, Uncomplicated veins 1 to 3 mm in diameter reticular veins, Uncomplicated veins <1 mm in diameter Spider Veins, Varicosities of the great saphenous vein

Clinical Trials

Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs

Phase 4

Withdrawn

Conditions: Venous Leg Ulcer
Varicose Veins Leg
Leg Ulcer
Veins, Varicose
Venous Reflux
Varicose Veins
Venous Ulcer
Reflux
Varicose Ulcer

Interventions: Drug: Polidocanol Endovenous Microfoam (PEM)

First Posted Date: 2016-12-09

Last Posted Date: 2017-09-15

Lead Sponsor: OhioHealth

Registration Number: NCT02988063

Locations: 🇺🇸
OhioHealth Riverside Methodist Hospital, Columbus, Ohio, United States

Polidocanol Versus Glucose Treatment of Telangiectasia Trial

Phase 4

Completed

Conditions: Varicose Veins
Telangiectasis

Interventions: Drug: Glucose
Drug: Polidocanol with Glucose

First Posted Date: 2016-01-15

Last Posted Date: 2018-01-04

Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Target Recruit Count: 115

Registration Number: NCT02657252

Locations: 🇧🇷
Vascular Lab, Botucatu, São Paulo, Brazil

COMFORT: A Multicenter, Open-label, Randomized, Crossover Study

Phase 4

Completed

Conditions: Varicose Veins

Interventions: Drug: Varithena®
Device: Radiofrequency ablation

First Posted Date: 2015-06-04

Last Posted Date: 2021-04-21

Lead Sponsor: Boston Scientific Corporation

Target Recruit Count: 35

Registration Number: NCT02462720

Locations: 🇺🇸
Venous Institute of Buffalo, Amherst, New York, United States
🇺🇸
Lake Washington Vascular, Bellevue, Washington, United States
🇺🇸
Coastal Vascular and Interventional, PLLC, Pensacola, Florida, United States

and more 1 locations

An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst

Phase 4

Terminated

Conditions: Ganglion Cysts

Interventions: Drug: polidocanol
Procedure: infra-red coagulation
Procedure: cryotherapy

First Posted Date: 2014-06-03

Last Posted Date: 2024-05-30

Lead Sponsor: University of Edinburgh

Target Recruit Count: 10

Registration Number: NCT02154789

Locations: 🇬🇧
Queen Margaret Hospital, Whitefield Road, Dunfermline, Fife, United Kingdom
🇬🇧
Department of Dermatology, Royal Infirmary, Edinburgh, Midlothian, United Kingdom

Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins

Phase 4

Completed

Conditions: Varicose Veins

Interventions: Drug: Polidocanol with Glucose
Drug: Glucose

First Posted Date: 2014-02-04

Last Posted Date: 2017-01-27

Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Target Recruit Count: 106

Registration Number: NCT02054325

Locations: 🇧🇷
School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil, Botucatu, SP, Brazil

Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

Phase 1

Completed

Conditions: Varicose Veins

Interventions: Drug: Polidocanol Endovenous Microfoam (PEM)

First Posted Date: 2011-09-02

Last Posted Date: 2021-04-21

Lead Sponsor: Boston Scientific Corporation

Target Recruit Count: 21

Registration Number: NCT01428076

Locations: 🇺🇸
Cardiovascular and Vein Center of Florida, Bradenton, Florida, United States

Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Phase 3

Completed

Conditions: Varicose Veins

Interventions: Drug: polidocanol injectable foam, 0.5%
Drug: Vehicle
Drug: polidocanol injectable foam, 0.125%
Drug: polidocanol injectable foam, 1.0%

First Posted Date: 2010-11-01

Last Posted Date: 2021-04-21

Lead Sponsor: Boston Scientific Corporation

Target Recruit Count: 235

Registration Number: NCT01231373

TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Phase 2

Conditions: Tendinopathy
Epicondylitis

Interventions: Drug: Polidocanol
Device: Focused extracorporeal shock wave therapy
Drug: Topical NO
Behavioral: Painful eccentric training in Achilles tendinopathy
Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board
Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar