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

NCT03429595 | Completed Phase 2

• 1 other identifier: ATx201-004
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 16

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.

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

• Incidences of Adverse Events and Laboratory Parameters

  incidences of adverse events reports and changes in significant laboratory parameters

  14 days

Study Arms (5)

Group 1: ATx201 GEL 2%

EXPERIMENTAL

Drug: ATx201

Group 2: ATx201 GEL 4%

EXPERIMENTAL

Drug: ATx201

Group 3: ATx201 GEL 4% plus vehicle

EXPERIMENTAL

Drug: ATx201; Other: ATx201 GEL Vehicle

Group 4: ATx201 GEL 4% plus vehicle

EXPERIMENTAL

Drug: ATx201; Other: ATx201 GEL Vehicle

Group 5: Vehicle

PLACEBO COMPARATOR

Other: ATx201 GEL Vehicle

Interventions

ATx201 DRUG

ATx201 GEL

Group 1: ATx201 GEL 2%; Group 2: ATx201 GEL 4%; Group 3: ATx201 GEL 4% plus vehicle; Group 4: ATx201 GEL 4% plus vehicle

ATx201 GEL Vehicle OTHER

Vehicle

Group 3: ATx201 GEL 4% plus vehicle; Group 4: ATx201 GEL 4% plus vehicle; Group 5: Vehicle

Eligibility Criteria

• Age: 9 Months - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (16)

AntibioTx Investigational Site

Bloemfontein, South Africa

Location

AntibioTx Investigative Site

Boksburg, South Africa

Location

AntibioTx Investigative Site

Claremont, South Africa

Location

AntibioTx Investigative Site

Durban, South Africa

Location

AntibioTx Investigative Site

eMkhomazi, South Africa

Location

AntibioTx Investigative Site

Germiston, South Africa

Location

AntibioTx Investigative Site 2

Johannesburg, South Africa

Location

AntibioTx Investigative Site

Johannesburg, South Africa

Location

AntibioTx Investigative Site

Kraaifontein, South Africa

Location

AntibioTx Investigative Site

Mpumalanga, South Africa

Location

AntibioTx Investigative Site

Paarl, South Africa

Location

AntibioTx Investigative Site 2

Port Elizabeth, South Africa

Location

AntibioTx Investigative Site

Port Elizabeth, South Africa

Location

AntibioTx Investigative Site

Pretoria, South Africa

Location

AntibioTx Investigative Site

Soshanguve, South Africa

Location

AntibioTx Investigative Site

Winnie Mandela, South Africa

Location

MeSH Terms

Conditions

Impetigo

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Prokocimer, MD

  CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 12, 2018
• Study Start: February 23, 2018
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (16)