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Int J Clin Exp Pathol 2011;4(6):587-595
Original Article
NVC-422 topical gel for the treatment of impetigo
Susan M. Iovino, Kenneth D. Krantz , Daisy M. Blanco, Josefina A. Fernández, Naomi Ocampo, Azar Najafi, Bahram Memarzadeh, Chris Celeri,
Dmitri Debabov, Behzad Khosrovi, Mark Anderson
NovaBay Pharmaceuticals Inc., Emeryville, CA, USA; Instituto Dermatológico, Santo Domingo, Dominican Republic; Robert Reid Cabral
Children’s Hospital, Santo Domingo, Dominican Republic.
Received June 8, 2011; accepted July 19; Epub July 23; published August 15, 2011
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. (IJCEP1106003).
Keywords: Impetigo, NVC-422, Clinical Phase 2, Staphylococcus, Streptococcus, MRSAs
Full text PDF
Address all correspondence to:
Mark B. Anderson, PhD
NovaBay Pharmaceuticals, Inc.
5980 Horton St # 550
Emeryville, CA. 94608, USA.
Tel: 510-219-5188
E-mail: manderson@novabaypharma.com
Original Article
NVC-422 topical gel for the treatment of impetigo
Susan M. Iovino, Kenneth D. Krantz , Daisy M. Blanco, Josefina A. Fernández, Naomi Ocampo, Azar Najafi, Bahram Memarzadeh, Chris Celeri,
Dmitri Debabov, Behzad Khosrovi, Mark Anderson
NovaBay Pharmaceuticals Inc., Emeryville, CA, USA; Instituto Dermatológico, Santo Domingo, Dominican Republic; Robert Reid Cabral
Children’s Hospital, Santo Domingo, Dominican Republic.
Received June 8, 2011; accepted July 19; Epub July 23; published August 15, 2011
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. (IJCEP1106003).
Keywords: Impetigo, NVC-422, Clinical Phase 2, Staphylococcus, Streptococcus, MRSAs
Full text PDF
Address all correspondence to:
Mark B. Anderson, PhD
NovaBay Pharmaceuticals, Inc.
5980 Horton St # 550
Emeryville, CA. 94608, USA.
Tel: 510-219-5188
E-mail: manderson@novabaypharma.com
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