Status:
COMPLETED
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
Lead Sponsor:
UNION therapeutics
Conditions:
Impetigo
Eligibility:
All Genders
9-70 years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03429595
Start Date
February 23 2018
End Date
June 26 2018
Last Update
July 31 2018
Active Locations (16)
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1
AntibioTx Investigational Site
Bloemfontein, South Africa
2
AntibioTx Investigative Site
Boksburg, South Africa
3
AntibioTx Investigative Site
Claremont, South Africa
4
AntibioTx Investigative Site
Durban, South Africa