Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.
Summary
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in 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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Congenital Venous Malformation
Intervention
Ethanol 96% Gel, Ethanol 98% Solution
Location
Johns Hopkins Medical Institutions
Baltimore
Maryland
United States
21287
Status
Recruiting
Source
Orfagen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00462462
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cadmium Chloride
A cadmium halide in the form of colorless crystals, soluble in water, methanol, and ethanol. It is used in photography, in dyeing, and calico printing, and as a solution to precipitate sulfides. (McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed)
Hydroxytryptophol
5-Hydroxy-indole-3-ethanol.
Alcoholic Beverages
Drinkable liquids containing ETHANOL.
Alcoholics
Persons who have a history of physical or psychological dependence on ETHANOL.
Venous Insufficiency
Impaired venous blood flow or venous return (venous stasis), usually caused by inadequate venous valves. Venous insufficiency often occurs in the legs, and is associated with EDEMA and sometimes with VENOUS STASIS ULCERS at the ankle.
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