Polidocanol Versus Glucose Treatment of Telangiectasia Trial

NCT ID: NCT02657252

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-11-30

Brief Summary

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. 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. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. 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 65 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 telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, 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 telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis.

Conditions

Varicose Veins; Telangiectasis

Study Design

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

Study Groups

Glucose

An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis 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

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DRUG

Sclerotherapy of telangiectasis in one lower limb.

Polidocanol with Glucose

An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis 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

Group Type: ACTIVE_COMPARATOR

Polidocanol with Glucose

Intervention Type: DRUG

Sclerotherapy of telangiectasis in one lower limb.

Interventions

Glucose

Sclerotherapy of telangiectasis in one lower limb.

Intervention Type: DRUG

Polidocanol with Glucose

Sclerotherapy of telangiectasis in one lower limb.

Intervention Type: DRUG

Other Intervention Names

Hypertonic dextrose; Asclera; Varithena

Eligibility Criteria

Inclusion Criteria

• females
• with telangiectasis on thigh side
• clinical classification of chronic venous disease C1(mild venous disease),
• minimum age of 18 year-old and maximum age 65 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
• don´t be 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: 65 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

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matheus Bertanha, Dr

Role: PRINCIPAL_INVESTIGATOR

Botucatu School of Medicine

Locations

Vascular Lab

Botucatu, São Paulo, Brazil

Countries

Brazil

References

Bertanha M, Camargo PA, Moura R, Yoshida WB, Pimenta RE, Mariuba JV, Alcantara GP, de Paula DR, Sobreira ML. Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial. Medicine (Baltimore). 2016 Sep;95(39):e4812. doi: 10.1097/MD.0000000000004812.

Reference Type: DERIVED

PMID: 27684809 (View on PubMed)

Other Identifiers

UPECLIN

Identifier Type: -

Identifier Source: org_study_id