SUBCUTANEOUS OXYGEN-OZONE THERAPY IN INDURATIVE HYPODERMALITIS AND IN LOCALISED
LIPODYSTROPHIES: A CLINICAL STUDY OF EFFICACY AND TOLERABILITY.
Franzini M., Bignamini A., Micheletti P., Valdenassi L., Agostini G., Richelmi P., Berte
SO ACTA TOXICOL. THER.
AB A multicentric, prospective, randomized, open study was carried out on confirmed by
clinical examination to determine the efficacy and tolerability of oxygen-ozone therapy as
compared with a topical preparation (Essaven gel). The experiments were carried out in 23
specialist centres and co-ordinated by the Institute of Pharmacology II, University of
The protocol included one or two weekly subcutaneous applications of medical oxygen-ozone
containing 1.2-5 microg/ml of ozone for 5 consecutive weeks in quantities of about 5-10 cc
per site with a maximum of 250 cc per application. Efficacy, determined by assessing the
circumference of the affected area (proportion of the variations equal to or morc than
8%), skin temperature and the overall clinical picture gave significantly better results
for oxygen-ozone therapy than the topical control.
Almost all the patients trcated with ozone presented local reactions of little
significance which did not interfere with the therapy. No adverse events of a systemic
nature were noted, not were there any clinically or statistically significant changes in
peripheral haemodynamics, haematology and clinical chemistry. the study shows the
significantly greater efficiency of oxygen-ozone therapy in the treatment of
lipodystrophies and indurative hypodermatites as compared with Essaven gel, a widely
used preparation clinical practice.
KY Ozone -- Drug Therapy -- DI/ Ozone -- Drug Comparison -- Cm/Ozone -- Clinical Trial --
CI/Oxygen -- Drug Therapy -- Dt/Oxygen -- Drug Comparison -- Cm/Oxygen -- Clinical Trial
-- Ct/Escin -- Drug Therapy -- Dt/Escin -- Drug Comparison -- Cm/Escin -- Clinical Trial
-- Ct/Lipodystrophy -- Drug Therapy -- Dt/Dermatitis -- Drug Therapy -- Dt/ Drug Efficacy
/ Drug Tolerance / Human / Controlled Study / Major Clinical Study / Clinical Trial /
Randomized Controlled Trial / Multicenter Study / Male / Female / Aged / Adult / Topical
Drug Administration / Article.
AN EMBASE 1994189760