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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Impetigo

Intervention / Treatment
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* Drug: ATx201
* Other: ATx201 GEL Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: ATx201 GEL 2%<br> | Drug: ATx201<br>* ATx201 GEL<br>|
| Experimental: Group 2: ATx201 GEL 4%<br> | Drug: ATx201<br>* ATx201 GEL<br>|
| Experimental: Group 3: ATx201 GEL 4% plus vehicle<br> | Drug: ATx201<br>* ATx201 GEL<br>Other: ATx201 GEL Vehicle<br>* Vehicle<br>|
| Experimental: Group 4: ATx201 GEL 4% plus vehicle<br> | Drug: ATx201<br>* ATx201 GEL<br>Other: ATx201 GEL Vehicle<br>* Vehicle<br>|
| Placebo Comparator: Group 5: Vehicle<br> | Other: ATx201 GEL Vehicle<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

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