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Completed

NCT Number: NCT03429595

Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel 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.

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Key information

Conditions

Impetigo Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections

Age range

9 month–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AntibioTx Investigational Site, Bloemfontein, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATx201

Drug

ATx201 GEL

ATx201 GEL Vehicle

Other

Vehicle

Primary outcomes

  1. Incidences of Adverse Events and Laboratory Parameters

    Time frame: 14 days

    incidences of adverse events reports and changes in significant laboratory parameters

Sponsors and collaborators

Lead sponsor

UNION therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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