Conditions: Congenital Venous Malformation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in order to minimize systemic and local diffusion capacities of ethanol. Therefore, the pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel 96% and absolute ethanol need to be carried out.

FDA Office of Orphan Products Development (FDA OOPD) : Funding source.

Detailed description:

Arms:
arm 1: Ethanol gel arm 2: Ethanol solution

Interventions: intervention 1: Ethanol 96% Gel intervention 2: Ethanol 98% Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: