NVC-422 topical gel for the treatment of impetigo

• Published in: International journal of clinical and experimental pathology 2011-08, Vol.4 (6), p.587-595
• Main Authors: Iovino, Susan M, Krantz, Kenneth D, Blanco, Daisy M, Fernández, Josefina A, Ocampo, Naomi, Najafi, Azar, Memarzadeh, Bahram, Celeri, Chris, Debabov, Dmitri, Khosrovi, Behzad, Anderson, Mark
• Format: Article
• Language: English
• Subjects: Administration, Topical; Anti-Bacterial Agents - pharmacology; Anti-Bacterial Agents - therapeutic use; Drug Resistance - drug effects; Female; Humans; Impetigo - drug therapy; Impetigo - pathology; Intention to Treat Analysis; Male; Methicillin-Resistant Staphylococcus aureus - metabolism; Microbial Sensitivity Tests; Original; Skin - drug effects; Skin - microbiology; Skin - pathology; Staphylococcus aureus - isolation & purification; Streptococcus pyogenes - isolation & purification; Taurine - analogs & derivatives; Taurine - pharmacology; Taurine - therapeutic use; Treatment Outcome
• ISSN: 1936-2625

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.