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Polidocanol Versus Glucose Treatment of Telangiectasia Trial (PG3T)

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ClinicalTrials.gov Identifier: NCT02657252
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : November 28, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Telangiectasis Drug: Glucose Drug: Polidocanol with Glucose Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Glucose
Sclerotherapy of telangiectasis in one lower limb.
Other Name: Hypertonic dextrose

Active Comparator: 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
Drug: Polidocanol with Glucose
Sclerotherapy of telangiectasis in one lower limb.
Other Names:
  • Asclera
  • Varithena




Primary Outcome Measures :
  1. Change From Baseline in Extent of Telangiectasias [ Time Frame: 2 months ]
    Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments


Secondary Outcome Measures :
  1. Skin Hyperpigmentation [ Time Frame: 2 months ]
    Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.

  2. Number of Participants With Deep Venous Thrombosis (DVT) [ Time Frame: 1 week ]
    Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657252


Locations
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Brazil
Vascular Lab
Botucatu, São Paulo, Brazil, 18618687
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Matheus Bertanha, Dr Botucatu School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Matheus Bertanha, Assistant professor, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT02657252     History of Changes
Other Study ID Numbers: UPECLIN
First Posted: January 15, 2016    Key Record Dates
Results First Posted: November 28, 2017
Last Update Posted: January 4, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp:
telangiectasis
varicose veins
veins
glucose
sclerotherapy

Additional relevant MeSH terms:
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Telangiectasis
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions