title: NVC-422 topical gel for the treatment of impetigo.
abstract: 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.
authors: NovaBay Pharmaceuticals Inc., Emeryville, CA 94605, USA.
authors: Susan M
authors: SM
authors: Iovino
authors: Kenneth D
authors: KD
authors: Krantz
authors: Daisy M
authors: DM
authors: Blanco
authors: Josefina A
authors: JA
authors: Fernández
authors: Naomi
authors: N
authors: Ocampo
authors: Azar
authors: A
authors: Najafi
authors: Bahram
authors: B
authors: Memarzadeh
authors: Chris
authors: C
authors: Celeri
authors: Dmitri
authors: D
authors: Debabov
authors: Behzad
authors: B
authors: Khosrovi
authors: Mark
authors: M
authors: Anderson
mesh_terms: D000287:Administration, Topical; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004351:Drug Resistance / Q000187:drug effects; D005260:Female; D006801:Humans; D007169:Impetigo / Q000188:drug therapy* / Q000473:pathology; D057194:Intention to Treat Analysis; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000378:metabolism; D008826:Microbial Sensitivity Tests; D012867:Skin / Q000187:drug effects / Q000382:microbiology / Q000473:pathology; D013211:Staphylococcus aureus / Q000302:isolation & purification; D013297:Streptococcus pyogenes / Q000302:isolation & purification; D013654:Taurine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D013654:Taurine; C560851:NVC-422