Overview

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

Status:
Completed
Trial end date:
2018-06-26
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AntibioTx A/S
UNION therapeutics
Criteria
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