Clinical trial NCT03429595: Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impetigo
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 210
Sex: ALL
Minimum age (years): 9
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidences of Adverse Events and Laboratory Parameters
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: AntibioTx Investigational Site
city: Boksburg
country: South Africa
facility: AntibioTx Investigative Site
city: Brandfort
country: South Africa
facility: AntibioTx Investigative Site
city: Claremont
country: South Africa
facility: AntibioTx Investigative Site
city: Durban
country: South Africa
facility: AntibioTx Investigative Site
city: Germiston
country: South Africa
facility: AntibioTx Investigative Site
city: Johannesburg
country: South Africa
facility: AntibioTx Investigative Site 2
city: Johannesburg
country: South Africa
facility: AntibioTx Investigative Site
city: Kraaifontein
country: South Africa
facility: AntibioTx Investigative Site
city: Mpumalanga
country: South Africa
facility: AntibioTx Investigative Site
city: Paarl
country: South Africa
facility: AntibioTx Investigative Site
city: Port Elizabeth
country: South Africa
facility: AntibioTx Investigative Site 2
city: Port Elizabeth
country: South Africa
facility: AntibioTx Investigative Site
city: Pretoria
country: South Africa
facility: AntibioTx Investigative Site
city: Soshanguve
country: South Africa
facility: AntibioTx Investigative Site
city: Umkomaas
country: South Africa
facility: AntibioTx Investigative Site
Study officials:
affiliation: CMO
name: Philippe Prokocimer, MD
role: STUDY_DIRECTOR
References: