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

A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: Polidocanol with Glucose; Drug: Glucose

Detailed Description

Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Reticular veins are those with less than 3mm diameter, bluish and important contribution to the aesthetic damage, and sometimes they are related to local pain and recurrence after treatment of telangiectasias. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.

Methods and design. One hundred lower limbs of healthy women between 18 and 69 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of reticular veins. The patients will be examined and clinically classified. It will be included patients with reticular veins sited at out's thigh/leg, measuring at least 10cm long, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.

Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of reticular veins of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for reticular veins.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Botucatu, SP, Brazil, 18607030
      • School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• females
• with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg
• clinical classification of chronic venous disease C1(mild venous disease),
• minimum age of 18 year-old and maximum age 69 year-old
• agreement with the study
• signing the free and informed consent ( IC)
• not use anticoagulant drugs .

Exclusion Criteria:

• male
• varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
• restrict mobility
• arterial insufficiency
• be allergic to any substance that may be related to the study drugs
• any cause of dermatitis on application site
• free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
• pregnancy
• previous deep vein thrombosis (DVT)
• family history of DVT
• thrombophilia
• do not agree with the search terms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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; Other Names: Varithena; Dodecylpolyethyleneglycolether; Aethoxysklerol
Active Comparator: Glucose; An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.	Drug: 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; Other Names: Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in Treating Reticular Veins by Photographs: Mean Percent 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.	Mean Percent of reticular vein disappearance two months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation 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).	Two months after treatment.

Collaborators and Investigators

• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Matheus Bertanha, Professor, UPECLIN HC FM Botucatu Unesp

Publications and helpful links

General Publications

• Bertanha M, Jaldin RG, Moura R, Pimenta REF, Mariuba JVO, Lucio Filho CEP, Alcantara GP, Padovani CR, Yoshida WB, Sobreira ML. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1249-1255. doi: 10.1001/jamadermatol.2017.3426.
• Bertanha M, Sobreira ML, Pinheiro Lucio Filho CE, de Oliveira Mariuba JV, Farres Pimenta RE, Jaldin RG, Moroz A, Moura R, Rollo HA, Yoshida WB. Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial. Trials. 2014 Dec 19;15:497. doi: 10.1186/1745-6215-15-497.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 1, 2014
• First Submitted That Met QC Criteria: February 1, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Sclerotherapy; varicose veins; veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: CEP 4127.2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We intend to present data when publish the original article.