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 α-bisabolol combination in the topical treatment of chronic venous leg ulcers was evaluated compared with standard epithelialization cream.


METHODS
A randomized controlled trial was conducted.


METHODS
A total of 29 patients older than 18 years with chronic venous leg ulcers for less than 2 years' duration were assessed.


METHODS
Patients were randomized to receive daily application of both ozonated oil and α-bisabolol or the control cream (vitamin A, vitamin E, talc, and zinc oxide) for 30 days.


METHODS
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.


RESULTS
At the end of treatment, the proportion of patients with complete ulcer healing was higher with ozonated oil and α-bisabolol formulation (25% vs 0%). Furthermore, the changes in ulcer surface area were significant for ozonated oil and α-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.


CONCLUSIONS
The innovative spray formulation of ozonated oil and α-bisabolol combination shows promise as an important new therapeutic option in the adjuvant treatment of venous ulcers.
Laura Gheucă Solovăstru, MD, PhD, is Associate Professor, Dermatology Department, Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania. Alina Stîncanu, MD, is a Dermatologist, Dermatology, Saint Spiridon Emergency Hospital, Iasi, Romania. Alessia De Ascentii, PhD, is a Scientist, Cosmoproject srl in Casale di Mezzani, and Neovalis srl, Parma, Italy. Guido Capparé, MD, is a General Practitioner, Lauderma Clinic, Iasi, Romania. Paolo Mattana is a Biologist and Scientific Advisor, Medical Service, Alfa Wassermann, Bologna, Italy. Dan Vâţă, MD, PhD, is Assistant Professor, Dermatology Department, Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania. Dr Solovăstru has disclosed that she was a consultant for Comsmoproject and was a member of the speakers' bureau for Pfizer and Berlin Chemie. Paolo Mattana has disclosed that his employer, Alfa Wassermann, is the pharmaceutical company that markets Azexin (the topical product base of ozonated oil and object of the study). The remaining coauthors have disclosed that they have no financial relationships related to this article. The authors have disclosed that the article discusses the investigational use of ozonated sunflower oil and α-bisabolol spray formulation in the topical treatment of chronic venous leg ulcers.
Laura Gheucă
LG
Solovăstru
Alina
A
Stîncanu
Alessia
A
De Ascentii
Guido
G
Capparé
Paolo
P
Mattana
Dan
D
Vâţă
D000287:Administration, Topical; D000336:Aerosols; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D000081222:Monocyclic Sesquiterpenes; D010126:Ozone / Q000008:administration & dosage*; D010938:Plant Oils / Q000008:administration & dosage; D012717:Sesquiterpenes / Q000008:administration & dosage*; D063465:Skin Cream / Q000008:administration & dosage; D000074242:Sunflower Oil; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects*
D000336:Aerosols; D003879:Dermatologic Agents; D000081222:Monocyclic Sesquiterpenes; D010938:Plant Oils; D012717:Sesquiterpenes; D000074242:Sunflower Oil; C004497:bisabolol; D010126:Ozone