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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03429595

Enrollment

210

Registered

2018-02-12

Start date

2018-02-23

Completion date

2018-06-26

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impetigo

Brief 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.

Interventions

DRUGATx201

ATx201 GEL

OTHERATx201 GEL Vehicle

Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups

Eligibility

Sex/Gender

ALL

Age

9 Months to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidences of Adverse Events and Laboratory Parameters	14 days	incidences of adverse events reports and changes in significant laboratory parameters

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026