Randomized, Controlled Study of Innovative Spray Formulation Containing Ozonated Oil and α-Bisabolol in the Topical Treatment of Chronic Venous Leg Ulcers

OBJECTIVE: Ozone therapy has a large clinical application in many therapeutic areas because of its well-known antimicrobial, immunological, and oxygenating properties. Recently, interest has grown regarding the application of ozonated oil for vascular leg ulcer treatment. The efficacy of an innovative spray formulation of ozonated oil and alpha-bisabolol combination in the topical treatment of chronic venous leg ulcers was evaluated compared with standard epithelialization cream. DESIGN: A randomized controlled trial was conducted. SETTING: A total of 29 patients older than 18 years with chronic venous leg ulcers for less than 2 years' duration were assessed. PATIENTS: Patients were randomized to receive daily application of both ozonated oil and alpha-bisabolol or the control cream (vitamin A, vitamin E, talc, and zinc oxide) for 30 days. MAIN OUTCOME MEASURES: Patients were evaluated on 4 different visits: at days 0, 7, 14, and 30. At each visit, the wound surfaces were measured. Wound area ratio and the speed of ulcer healing were calculated. MAIN RESULTS: At the end of treatment, the proportion of patients with complete ulcer healing was higher with ozonated oil and alpha-bisabolol formulation (25% vs 0%). Furthermore, the changes in ulcer surface area were significant for ozonated oil and alpha-bisabolol formulation only (P < .05), in particular, observing a significant and progressive reduction of the wound surface by 34%, 59%, and 73%, after 7, 14, and 30 days of treatment, respectively. CONCLUSION: The innovative spray formulation of ozonated oil and alpha-bisabolol combination shows promise as an important new therapeutic option in the adjuvant treatment of venous ulcers.