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Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

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ClinicalTrials.gov Identifier: NCT01072877
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : May 16, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Varicose Veins
Interventions Drug: Polidocanol injectable foam (PEM)
Drug: Placebo Vehicle
Enrollment 279
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Polidocanol Endovenous Microfoam 0.125% Polidocanol Endovenous Microfoam 0.5% Polidocanol Endovenous Microfoam 1.0% Polidocanol Endovenous Microfoam 2.0%
Hide Arm/Group Description

Injection of vehicle comparator

Placebo Vehicle: Placebo vehicle

Polidocanol endovenous microfoam 0.125%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol endovenous microfoam 0.5%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol endovenous microfoam 1.0%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol endovenous microfoam 2.0%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Period Title: Overall Study
Started 56 57 51 52 63
Completed 55 56 51 50 63
Not Completed 1 1 0 2 0
Reason Not Completed
Lost to Follow-up             1             1             0             2             0
Arm/Group Title Vehicle Polidocanol Injectable Foam 0.125% Polidocanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Injectable Foam 2.0% Total
Hide Arm/Group Description

Injection of vehicle comparator

Placebo Vehicle: Placebo vehicle

Polidocanol injectable foam 0.125% Polidocanol injectable foam 0.5% Polidocanol injectable foam 1.0% Polidocanol injectable foam2.0% Total of all reporting groups
Overall Number of Baseline Participants 56 57 51 52 63 279
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 57 participants 51 participants 52 participants 63 participants 279 participants
46.0  (11.31) 51.6  (9.60) 48.2  (11.78) 48.8  (8.78) 49.7  (10.49) 48.9  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 57 participants 51 participants 52 participants 63 participants 279 participants
Female
44
  78.6%
42
  73.7%
37
  72.5%
38
  73.1%
47
  74.6%
208
  74.6%
Male
12
  21.4%
15
  26.3%
14
  27.5%
14
  26.9%
16
  25.4%
71
  25.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 57 participants 51 participants 52 participants 63 participants 279 participants
American Indian or Alaska Native
3
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.1%
Asian
1
   1.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
2
   3.9%
0
   0.0%
0
   0.0%
2
   0.7%
Black or African American
0
   0.0%
4
   7.0%
1
   2.0%
1
   1.9%
1
   1.6%
7
   2.5%
White
52
  92.9%
51
  89.5%
46
  90.2%
50
  96.2%
61
  96.8%
260
  93.2%
More than one race
0
   0.0%
2
   3.5%
2
   3.9%
1
   1.9%
1
   1.6%
6
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 56 participants 57 participants 51 participants 52 participants 63 participants 279 participants
27.7  (5.95) 28.8  (5.77) 27.4  (5.75) 28.6  (5.41) 28.3  (5.40) 28.2  (5.64)
1.Primary Outcome
Title Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Polidocanol Injectable Foam 0.125% Polidocanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Injectable Foam 2.0%
Hide Arm/Group Description:

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol injectable foam at a 0.125% concentration
polidocanol injectable foam at a 0.5% concentration
Polidocanol injectable foam at 1.0% concentration
Polidocanol injectable foam at a 2.0% concentration
Overall Number of Participants Analyzed 55 56 51 50 63
Mean (Standard Error)
Unit of Measure: units on a scale
2.13  (0.452) 4.63  (0.447) 5.68  (0.483) 4.87  (0.477) 5.78  (0.425)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.125%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.49
Confidence Interval (2-Sided) 95%
-3.72 to -1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.5%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.54
Confidence Interval (2-Sided) 95%
-4.80 to -2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 1.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.73
Confidence Interval (2-Sided) 95%
-3.98 to -1.48
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 2.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.65
Confidence Interval (2-Sided) 95%
-4.84 to -2.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Hide Description The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4).
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle Polidocanol Injectable Foam 0.125% Polidocanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Injectable Foam 2.0%
Hide Arm/Group Description:

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol injectable foam at a 0.125% concentration
Polidocanol injectable foam at a 0.5% concentration
Polidocanol injectable foam at a 1.0% concentration
Polidocanol injectable foam at a 2.0% concentration
Overall Number of Participants Analyzed 55 56 51 50 63
Mean (Standard Error)
Unit of Measure: units on a scale
-0.15  (0.143) -0.93  (0.142) -1.40  (0.152) -1.60  (0.151) -1.75  (0.135)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.125%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.17 to -0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.5%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 95%
-1.65 to -0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 1.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-1.85 to -1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 2.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-1.98 to -1.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Time Frame 8 weeks post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population consists of all patients who had a baseline and on-treatment assessment.
Arm/Group Title Vehicle Polidocanol Injectable Foam 0.125% Polidocanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Injectable Foam 2.0%
Hide Arm/Group Description:

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol injectable foam at a 0.125% concentration
Polidocanol injectable foam at a 0.5% concentration
Polidocanol injectable foam at a 1.0% concentration
Polidocanol injectable foam at a 2.0% concentration
Overall Number of Participants Analyzed 55 56 51 49 61
Mean (Standard Error)
Unit of Measure: units on a scale
-0.01  (0.081) -0.46  (0.080) -0.77  (0.086) -0.76  (0.085) -0.91  (0.077)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.125%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.66 to -0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 0.5%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-0.98 to -0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 1.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-0.97 to -0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle, Polidocanol Injectable Foam 2.0%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.11 to -0.68
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Polidocanol Injectable Foam 0.125% Polidcanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Endovenous Microfoam 2.0%
Hide Arm/Group Description

Injection of vehicle

Placebo Vehicle: Placebo vehicle

polidocanol injectable foam at a 0.125% concentration polidocanol injectable foam at a 0.5% concentration polidocanol injectable foam at a 1.0% concentration polidocanol injectable foam at a 2.0% concentration
All-Cause Mortality
Vehicle Polidocanol Injectable Foam 0.125% Polidcanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Endovenous Microfoam 2.0%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Polidocanol Injectable Foam 0.125% Polidcanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Endovenous Microfoam 2.0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/57 (0.00%)      0/51 (0.00%)      0/52 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Polidocanol Injectable Foam 0.125% Polidcanol Injectable Foam 0.5% Polidocanol Injectable Foam 1.0% Polidocanol Endovenous Microfoam 2.0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/56 (35.71%)      38/57 (66.67%)      46/51 (90.20%)      41/52 (78.85%)      50/63 (79.37%)    
Infections and infestations           
Upper respiratory tract infection   0/56 (0.00%)  0 3/57 (5.26%)  3 2/51 (3.92%)  2 0/52 (0.00%)  0 3/63 (4.76%)  3
Musculoskeletal and connective tissue disorders           
Pain in extremity   5/56 (8.93%)  5 11/57 (19.30%)  11 10/51 (19.61%)  10 10/52 (19.23%)  10 6/63 (9.52%)  6
Limb discomfort   2/56 (3.57%)  2 2/57 (3.51%)  2 3/51 (5.88%)  3 3/52 (5.77%)  3 6/63 (9.52%)  6
Injection site pain   2/56 (3.57%)  2 3/57 (5.26%)  3 4/51 (7.84%)  4 3/52 (5.77%)  3 3/63 (4.76%)  3
Infusion site thrombosis   0/56 (0.00%)  0 0/57 (0.00%)  0 3/51 (5.88%)  3 3/52 (5.77%)  3 6/63 (9.52%)  6
Nervous system disorders           
Headache   3/56 (5.36%)  3 2/57 (3.51%)  2 2/51 (3.92%)  2 3/52 (5.77%)  3 3/63 (4.76%)  3
Skin and subcutaneous tissue disorders           
Pruritis   3/56 (5.36%)  3 2/57 (3.51%)  2 2/51 (3.92%)  2 2/52 (3.85%)  2 6/63 (9.52%)  6
Extravasation   1/56 (1.79%)  1 1/57 (1.75%)  1 1/51 (1.96%)  1 4/52 (7.69%)  4 1/63 (1.59%)  1
Vascular disorders           
Thrombophlebitis superficial   1/56 (1.79%)  1 7/57 (12.28%)  7 5/51 (9.80%)  5 4/52 (7.69%)  4 8/63 (12.70%)  8
Injection site hematoma   1/56 (1.79%)  1 3/57 (5.26%)  3 8/51 (15.69%)  8 4/52 (7.69%)  4 3/63 (4.76%)  3
Venous thrombosis limb   0/56 (0.00%)  0 1/57 (1.75%)  1 3/51 (5.88%)  3 6/52 (11.54%)  6 4/63 (6.35%)  4
Edema peripheral   2/56 (3.57%)  2 3/57 (5.26%)  3 3/51 (5.88%)  3 2/52 (3.85%)  2 1/63 (1.59%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Wright MB FRCS
Organization: BTG International Inc
Phone: 610-278-1660
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01072877     History of Changes
Other Study ID Numbers: VAP.VV015
First Submitted: February 19, 2010
First Posted: February 22, 2010
Results First Submitted: January 15, 2014
Results First Posted: May 16, 2014
Last Update Posted: March 10, 2015