Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo

Randomized, Double-Blind, Vehicle Controlled, Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of Topical ATx201 GEL (2% and 4%) in Outpatients With Impetigo

This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.

Inclusion Criteria:

• diagnosis of primary nonbullous or bullous impetigo
• affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.
• target area has total SIRS score of at least 3, including pus/exudate of at least 1
• normally active and otherwise in good health by medical history and physical examination

Exclusion Criteria:

• has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection
• has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy
• clinically significant mental illness
• pregnant or breast-feeding
• recent history, or strong potential for, alcohol or substance abuse.
• skin condition that may interfere with the placement of study treatment or impede clinical evaluations
• receipt of systemic drugs that affect the immune system within the past 3 months
• receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours