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Polidocanol injectable foam 0.125% for Varicose Veins (VANISH-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
Approved for 10 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved

Summary

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.

Eligible Conditions
  • Varicose Veins
  • Variceal Bleeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Varicosity
Secondary study objectives
Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)

Side effects data

From 2012 Phase 3 trial • 279 Patients • NCT01072877
9%
Pain in extremity
5%
Headache
5%
Pruritis
4%
Limb discomfort
4%
Edema peripheral
4%
Injection site pain
2%
Thrombophlebitis superficial
2%
Extravasation
2%
Injection site hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
Polidcanol Injectable Foam 0.5%
Polidocanol Endovenous Microfoam 2.0%
Polidocanol Injectable Foam 1.0%
Polidocanol Injectable Foam 0.125%

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Polidocanol injectable foam 2.0%Experimental Treatment1 Intervention
Polidocanol injectable foam 2.0%
Group II: Polidocanol injectable foam 1.0%Experimental Treatment1 Intervention
Polidocanol injectable foam 1.0%
Group III: Polidocanol injectable foam 0.5%Experimental Treatment1 Intervention
Polidocanol injectable foam 0.5%
Group IV: Polidocanol injectable foam 0.125%Experimental Treatment1 Intervention
Polidocanol injectable foam 0.125%
Group V: VehiclePlacebo Group1 Intervention
Injection of vehicle comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polidocanol
FDA approved

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
743 Previous Clinical Trials
857,116 Total Patients Enrolled
9 Trials studying Varicose Veins
649 Patients Enrolled for Varicose Veins
~19 spots leftby Nov 2025
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