Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: June 26, 2018
Interventions
- Drug: ATx201
- ATx201 GEL
- Other: ATx201 GEL Vehicle
- Vehicle
Arms, Groups and Cohorts
- Experimental: Group 1: ATx201 GEL 2%
- Experimental: Group 2: ATx201 GEL 4%
- Experimental: Group 3: ATx201 GEL 4% plus vehicle
- Experimental: Group 4: ATx201 GEL 4% plus vehicle
- Placebo Comparator: Group 5: Vehicle
Clinical Trial Outcome Measures
Primary Measures
- Incidences of Adverse Events and Laboratory Parameters
- Time Frame: 14 days
- incidences of adverse events reports and changes in significant laboratory parameters
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 9 Months
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- UNION therapeutics
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Philippe Prokocimer, MD, Study Director, CMO
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