Impetigo is a highly contagious bacterial skin infection affecting children worldwide that is caused by the Gram-positive bacteria Staphylococcus aureus, Streptococcus pyogenes, or both. Staphylococcus species can quickly develop drug resistance rendering mupirocin, fusidic acid, and erythromycin ineffective. Preclinical and clinical studies demonstrated that NVC-422 (N, N-dichloro-2, 2-dimethyltaurine) rapidly kills pathogens without the development of drug resistance. 129 patients with clinically diagnosed impetigo were randomized to three dose groups (0.1, 0.5, or 1.5% NVC-422 topical gel) in a study conducted at 2 centers; 125 patients (97%) had microbiologically confirmed infection. Treatment was administered three times a day (TID) for 7 days to all randomized subjects. Response was measured at the completion of treatment (Day 8) and 1 week post treatment (Day 15) by the Skin Infection Rating Scale (SIRS) and by microbiological response. A total of 120 subjects (96%) completed all 7 days of treatment and were assessed at end of treatment (EOT). Clinical response rate at EOT in the PPC population was excellent in each of the dose groups (84.6%, 87.2%, and 92.3% in the 0.1%, 0.5% and 1.5% dose groups respectively). The majority of the infections were caused by S. aureus, alone (106/125, 85%) of which approximately 10% were MRSA. There were no clinical recurrences in any treatment groups. Treatment-emergent adverse events were seen in 5.4% of the subjects (7/129) and were mild to moderate and resolved. NVC-422 topical gel administered TID was well tolerated, with high rates of clinical and microbiological responses for treating impetigo
To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.