drugset / Trial / NCT02054325
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Phase 4
Completed
106 enrolled
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glucose | Unknown | 70 % | — |
| Comparator | Glucose | Unknown | 75 % | — |
| Comparator | Polidocanol | Other / unclassified | 0.2 % | — |