Clinical trial NCT02054325: Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Official title: A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Veins
Keywords: Sclerotherapy
varicose veins
veins
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-02-04
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.
timeFrame: Mean Percent of reticular vein disappearance two months after treatment
Secondary outcomes:
measure: The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment
timeFrame: Two months after treatment.
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil
state: SP
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Matheus Bertanha, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.