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

Impetigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429595
• Other study ID #: ATx201-004
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2018
• Est. completion date: June 26, 2018

Study information

• Verified date: July 2018
• Source: AntibioTx A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• ATx201
ATx201 GEL

Other:
• ATx201 GEL Vehicle
Vehicle

Locations

Country	Name	City	State
South Africa	AntibioTx Investigational Site	Bloemfontein
South Africa	AntibioTx Investigative 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

Sponsors (1)

Lead Sponsor	Collaborator
AntibioTx A/S

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of Adverse Events and Laboratory Parameters	incidences of adverse events reports and changes in significant laboratory parameters	14 days