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

NCT ID: NCT02054325

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Polidocanol with Glucose

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Dodecylpolyethyleneglycolether; Aethoxysklerol; Varithena; Dextrose

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

Dr Matheus Bertanha

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matheus Bertanha, Professor

Role: PRINCIPAL_INVESTIGATOR

UPECLIN HC FM Botucatu Unesp

Locations

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

Botucatu, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28973414 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25527165 (View on PubMed)

Other Identifiers

CEP 4127.2012

Identifier Type: -

Identifier Source: org_study_id