Trial Outcomes & Findings for Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins (NCT NCT02054325)

NCT ID: NCT02054325

Last Updated: 2017-01-27

Results Overview

Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 106 participants
• Primary outcome timeframe: Mean Percent of reticular vein disappearance two months after treatment
• Results posted on: 2017-01-27

Participant Flow

Some patients (n=6) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 6 more patients.

Participant milestones

Measure	Polidocanol With Glucose An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Overall Study STARTED	51	55
Overall Study COMPLETED	43	50
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Measure	Polidocanol With Glucose An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Overall Study Lost to Follow-up	8	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Polidocanol With Glucose n=43 Participants An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose n=50 Participants An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=93 Participants	50 Participants n=4 Participants	93 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Gender Female	43 Participants n=93 Participants	50 Participants n=4 Participants	93 Participants n=27 Participants
Gender Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Mean Percent of reticular vein disappearance two months after treatment

Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.

Outcome measures

Measure	Polidocanol With Glucose n=43 Participants An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose n=50 Participants An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.	95.17 % of Reticular Veins that Disappeared Standard Deviation 9.09	85.40 % of Reticular Veins that Disappeared Standard Deviation 17.04

SECONDARY outcome

Timeframe: Two months after treatment.

Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as "Yes" or "No". Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD).

Outcome measures

Measure	Polidocanol With Glucose n=43 Participants An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose n=50 Participants An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment	5.75 Percent of Skin Hyperpigmentation Standard Deviation 7.02	9.66 Percent of Skin Hyperpigmentation Standard Deviation 11.67

Adverse Events

Polidocanol With Glucose

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Glucose

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Polidocanol With Glucose n=43 participants at risk An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects	Glucose n=50 participants at risk An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Skin and subcutaneous tissue disorders Hyperpigmentation	51.2% 22/43 • Right after two months post procedure Hyperpigmentation: Linear measure above the projection area of hyperpigmentation post procedure. The length of this line was provided by the Image J software (ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health)	62.0% 31/50 • Right after two months post procedure Hyperpigmentation: Linear measure above the projection area of hyperpigmentation post procedure. The length of this line was provided by the Image J software (ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health)

Additional Information

Dr. Matheus Bertanha

UPECLIN

Phone: +55 14 38116305

Email: matheus.fameca@ig.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place