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

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.

Study Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: ATx201; Other: ATx201 GEL Vehicle

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa
    • AntibioTx Investigational Site
  • Boksburg, South Africa
    • AntibioTx Investigative Site
  • Brandfort, South Africa
    • AntibioTx Investigative Site
  • Claremont, South Africa
    • AntibioTx Investigative Site
  • Durban, South Africa
    • AntibioTx Investigative Site
  • Germiston, South Africa
    • AntibioTx Investigative Site
  • Johannesburg, South Africa
    • AntibioTx Investigative Site 2
  • Johannesburg, South Africa
    • AntibioTx Investigative Site
  • Kraaifontein, South Africa
    • AntibioTx Investigative Site
  • Mpumalanga, South Africa
    • AntibioTx Investigative Site
  • Paarl, South Africa
    • AntibioTx Investigative Site
  • Port Elizabeth, South Africa
    • AntibioTx Investigative Site 2
  • Port Elizabeth, South Africa
    • AntibioTx Investigative Site
  • Pretoria, South Africa
    • AntibioTx Investigative Site
  • Soshanguve, South Africa
    • AntibioTx Investigative Site
  • Umkomaas, South Africa
    • AntibioTx Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: ATx201 GEL 2%	Drug: ATx201; ATx201 GEL
EXPERIMENTAL: Group 2: ATx201 GEL 4%	Drug: ATx201; ATx201 GEL
EXPERIMENTAL: Group 3: ATx201 GEL 4% plus vehicle	Drug: ATx201; ATx201 GEL; Other: ATx201 GEL Vehicle; Vehicle
EXPERIMENTAL: Group 4: ATx201 GEL 4% plus vehicle	Drug: ATx201; ATx201 GEL; Other: ATx201 GEL Vehicle; Vehicle
PLACEBO_COMPARATOR: Group 5: Vehicle	Other: ATx201 GEL Vehicle; Vehicle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNION therapeutics
• Investigators: Study Director: Philippe Prokocimer, MD, CMO

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2018
• Primary Completion (ACTUAL): June 26, 2018
• Study Completion (ACTUAL): June 26, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (ACTUAL): February 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo
• Other Study ID Numbers: ATx201-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No