The Prevstain Trial — TPT  

Varicose Veins Clinical Trial

Official title: Double Blind Randomized Clinical Trial Comparing Pycnogenol Versus Placebo for Pigmentation Prevention After Treatment With Varicose Veins With Foam Sclerotherapy

Status Not yet recruiting

Clinical Trial Summary

To evaluate whether oral supplementation with Pycnogenol (Flebon®) can interfere with skin hyperpigmentation after polidocanol foam sclerotherapy in patients with mild to moderate chronic venous insufficiency (CEAP C2 and C3) compared with the use of Placebo.

Clinical Trial Description

A randomized double-blind study with research centers in the state of São Paulo (Hospital das Clínicas de São Paulo (HC-SP)) is proposed. Treatment groups: Group 1: Elastic stockings + FlebonGroup 2: Use of elastic socks + Placebo de Flebon.1 Visit 1 - Screening and Selection (D-15) • Evaluation of inclusion and non-inclusion criteria • FICT signature • Clinical evaluation • Aberdeen questionnaire (without schematic design) • Randomization • Dispensation of medication (placebo and Pycnogenol) • Dismissal of use diary 2. Visit 02 D0 - Initiation of treatment (+/- 2 days) • Performing the procedure by Sclerotherapy • Record of adverse events • Pre-sclerotherapy photographic record • Clinical evaluation • investigational product (placebo and Pycnogenol) • Dismissal of new use diary (elastic stockings and investigational product) • Withdrawal criteria • Visit 03 - D7 - Return of 7 days (+/- 2 days) • Evaluation of withdrawal criteria • Evaluated adherence to treatment by use diary • Return of control (eventual drainage) • Record of adverse events • Clinical evaluationVisit 04 - D30 - Return 30 days after visit 2 (+/- 2 days) • Treatment adherence assessment by use diary • Photographic control I • Hyperpigmentation scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment clinical • Investigational Product Dispensation (Placebo and Pycnogenol) • New Usage Diary DispensationView 05- D60 - Return 60 Days After Sight 3 (+/- 2 days) • Usage Diary Treatment Adherence Assessment • Photographic Control II • Hyperpigmentation Scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment • Dispensation of medication (placebo and Pycnogenol) • Dispensation of new use diaryVisit 06 -D90 - Return 90 days after sight 04 (+/- 2 days) • Evaluation of treatment adherence by use diary • Evaluation of criteria • Photographic control III •Pigment size assessment, if any • Aberdeen questionnaire application (without schematic drawing) • Medication suspension • Hyperpigmentation scale • Adverse event recording • Research participant satisfaction rating • Clinical assessmentPhotographic recording of the legs will be performed before 30, 60 and 90 days in 03 (three) incidences and evaluated by 01 blind observer. The photographic records will be made by camera following the same parameters, namely: 60 cm distance to 50 cm from the ground, not using flash, with artificial lighting (ceiling light), without zoom. All generated images will be archived in JPEG (Joint Photographic File Format) format. Images must be downloaded within 5 days of photographic registration and inserted into All images should be encoded as follows: IDENTIFICATION OF PARTICIPANTS + DATE OF PHOTOGRAPH REGISTRATION CO (00/00/0000) + VISIT. In addition, a sticker with the research participant's initials and date of photograph registration should be visible to the image. The blinded study medium will evaluate all photographs at the end of the study, making a comparison between them to inform the presence and the evolution of hyperpigmentation due to foam sclerotherapy, when they occur.For this, the Torok Hyperpigmentation Scale will be applied at D 30, D 60 and D90. ;

Related Conditions & MeSH terms

• Varicose Veins

• NCT number: NCT04203043
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 28, 2020
• Completion date: December 28, 2021