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

Primary Purpose

Impetigo

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
ATx201
ATx201 GEL Vehicle
Sponsored by
UNION therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impetigo

Eligibility Criteria

9 Months - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AntibioTx Investigational Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site 2
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site 2
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site
  • AntibioTx Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: ATx201 GEL 2%

Group 2: ATx201 GEL 4%

Group 3: ATx201 GEL 4% plus vehicle

Group 4: ATx201 GEL 4% plus vehicle

Group 5: Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Incidences of Adverse Events and Laboratory Parameters
incidences of adverse events reports and changes in significant laboratory parameters

Secondary Outcome Measures

Full Information

First Posted
February 6, 2018
Last Updated
July 30, 2018
Sponsor
UNION therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03429595
Brief Title
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: ATx201 GEL 2%
Arm Type
Experimental
Arm Title
Group 2: ATx201 GEL 4%
Arm Type
Experimental
Arm Title
Group 3: ATx201 GEL 4% plus vehicle
Arm Type
Experimental
Arm Title
Group 4: ATx201 GEL 4% plus vehicle
Arm Type
Experimental
Arm Title
Group 5: Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ATx201
Intervention Description
ATx201 GEL
Intervention Type
Other
Intervention Name(s)
ATx201 GEL Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Incidences of Adverse Events and Laboratory Parameters
Description
incidences of adverse events reports and changes in significant laboratory parameters
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Prokocimer, MD
Organizational Affiliation
CMO
Official's Role
Study Director
Facility Information:
Facility Name
AntibioTx Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Boksburg
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Brandfort
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Claremont
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Durban
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Germiston
Country
South Africa
Facility Name
AntibioTx Investigative Site 2
City
Johannesburg
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Johannesburg
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Kraaifontein
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Mpumalanga
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Paarl
Country
South Africa
Facility Name
AntibioTx Investigative Site 2
City
Port Elizabeth
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Port Elizabeth
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Pretoria
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Soshanguve
Country
South Africa
Facility Name
AntibioTx Investigative Site
City
Umkomaas
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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

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