SUBCUTANEOUS OXYGEN-OZONE THERAPY IN INDURATIVE HYPODERMALITIS AND IN LOCALISED LIPODYSTROPHIES: A CLINICAL STUDY OF EFFICACY AND TOLERABILITY.

AU Franzini M., Bignamini A., Micheletti P., Valdenassi L., Agostini G., Richelmi P., Berte F..
SO ACTA TOXICOL. THER.
YR 1993
PG 273-288
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 Pavia.
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.
DE RCT
AN EMBASE 1994189760