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

Phase 2

Completed

• Conditions: Impetigo
• Interventions: Drug: ATx201; Other: ATx201 GEL Vehicle

• Registration Number: NCT03429595
• Lead Sponsor: UNION therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-12
• Study Start: 2018-02-23
• Primary Completion: 2018-06-26
• Study Completion: 2018-06-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: ATx201 GEL 4% plus vehicle	ATx201 GEL Vehicle	-
Group 4: ATx201 GEL 4% plus vehicle	ATx201 GEL Vehicle	-
Group 5: Vehicle	ATx201 GEL Vehicle	-
Group 3: ATx201 GEL 4% plus vehicle	ATx201	-
Group 4: ATx201 GEL 4% plus vehicle	ATx201	-
Group 1: ATx201 GEL 2%	ATx201	-
Group 2: ATx201 GEL 4%	ATx201	-

Primary Outcome Measures

Name	Time	Method
Incidences of Adverse Events and Laboratory Parameters	14 days	incidences of adverse events reports and changes in significant laboratory parameters

Trial Locations

Locations (3)

AntibioTx Investigational Site; 🇿🇦 Bloemfontein, South Africa

AntibioTx Investigative Site; 🇿🇦 Umkomaas, South Africa

AntibioTx Investigative Site 2; 🇿🇦 Port Elizabeth, South Africa