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

NCT ID: NCT03429595

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2018-06-26

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.

Detailed Description

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Conditions

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Impetigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: ATx201 GEL 2%

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

ATx201 GEL

Group 2: ATx201 GEL 4%

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

ATx201 GEL

Group 3: ATx201 GEL 4% plus vehicle

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

ATx201 GEL

ATx201 GEL Vehicle

Intervention Type OTHER

Vehicle

Group 4: ATx201 GEL 4% plus vehicle

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

ATx201 GEL

ATx201 GEL Vehicle

Intervention Type OTHER

Vehicle

Group 5: Vehicle

Group Type PLACEBO_COMPARATOR

ATx201 GEL Vehicle

Intervention Type OTHER

Vehicle

Interventions

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ATx201

ATx201 GEL

Intervention Type DRUG

ATx201 GEL Vehicle

Vehicle

Intervention Type OTHER

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
Minimum Eligible Age

9 Months

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNION therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Prokocimer, MD

Role: STUDY_DIRECTOR

CMO

Locations

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AntibioTx Investigational Site

Bloemfontein, , South Africa

Site Status

AntibioTx Investigative Site

Boksburg, , South Africa

Site Status

AntibioTx Investigative Site

Claremont, , South Africa

Site Status

AntibioTx Investigative Site

Durban, , South Africa

Site Status

AntibioTx Investigative Site

eMkhomazi, , South Africa

Site Status

AntibioTx Investigative Site

Germiston, , South Africa

Site Status

AntibioTx Investigative Site 2

Johannesburg, , South Africa

Site Status

AntibioTx Investigative Site

Johannesburg, , South Africa

Site Status

AntibioTx Investigative Site

Kraaifontein, , South Africa

Site Status

AntibioTx Investigative Site

Mpumalanga, , South Africa

Site Status

AntibioTx Investigative Site

Paarl, , South Africa

Site Status

AntibioTx Investigative Site 2

Port Elizabeth, , South Africa

Site Status

AntibioTx Investigative Site

Port Elizabeth, , South Africa

Site Status

AntibioTx Investigative Site

Pretoria, , South Africa

Site Status

AntibioTx Investigative Site

Soshanguve, , South Africa

Site Status

AntibioTx Investigative Site

Winnie Mandela, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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ATx201-004

Identifier Type: -

Identifier Source: org_study_id