Ozenoxacin cream an effective novel impetigo treatment for children and adults
By Lorraine L. Janeczko
NEW YORK (Reuters Health) - Topical ozenoxacin offers a novel, effective and well-tolerated treatment option for impetigo in patients 2 months of age and older, industry-funded research suggest.
Ozenoxacin, a topical impetigo treatment with potent bactericidal activity against gram-positive bacteria, was approved in December 2017 by the U.S. Food and Drug Administration and is available as a cream with 1% active drug.
"This study shows that this new topical therapy is very effective at treating impetigo, including impetigo from organisms that are resistant to the traditional topical therapies. The medication is well-tolerated and has a good safety profile," Dr. Ida F. Orengo, who was not involved in the study, told Reuters Health by email.
"It is good that this new therapy works on methicillin-resistant staph. If it is not cost prohibitive, it will be a first line of therapy for patients with impetigo and have few, if any, side effects," added Dr. Orengo, director of the Mohs/Dermatologic Surgery Unit and medical director of the Department of Dermatology at Baylor College of Medicine in Houston, Texas.
In their second phase 3 pivotal study of the drug, Dr. Theodore Rosen, also at Baylor, and colleagues conducted a randomized, double-blind trial that enrolled patients between 2 months and 80 years of age with impetigo from 2014 to 2015 at treatment centers in six countries. The results appeared online June 13 in JAMA Dermatology.
Patients received either topical ozenoxacin cream, 1%, or placebo. During the five-day treatment period, the participants or their caregivers applied the cream to the affected areas twice a day.
The researchers measured efficacy using the microbiological culture and the Skin Infection Rating Scale, and they assessed safety and tolerability.
After two days of therapy, ozenoxacin showed microbiological success in 109 of the 125 patients (87.2%) in the treatment group compared with 76 of 119 (63.9%) in the placebo group (P=0.002).
After five days of therapy, 112 of 206 (54.4%) participants in the treatment group experienced clinical success, defined as total absence of the treated lesions, versus 78 of 206 (37.9%) in the placebo group (P=0.001).
The drug was well tolerated with no serious adverse effects. Eight of 206 patients in the active arm and seven of 205 in the placebo arm reported adverse effects; one event in the active arm (a case of rosacea and seborrheic dermatitis) and two (dermatitis and skin tightness) were judged potentially related to the treatment.
These results confirmed the results of the first pivotal study of ozenoxacin.
"Impetigo is a common condition in children, and it is good that we can find topical therapies to treat it instead of using systemic therapies, where there is a greater chance of adverse side effects. It is also important to find therapies to treat methicillin-resistant staph, which can go on to have serious consequences if left untreated," Dr. Orengo said.
Dr. Orengo noted that, while a limitation of the study is that it did not include many children under 6 months of age, its large placebo-controlled design is a strength.
"If this medication is readily available and not cost prohibitive, it will be an excellent first line of therapy for patients with impetigo," she concluded.
Ferrer Internacional, SA, funded the study and was involved in all parts of it, including manuscript preparation. Dr. Orengo has no ties to the company.
JAMA Dermatol 2018.(c) Copyright Thomson Reuters 2018. Click For Restrictions - https://agency.reuters.com/en/copyright.html