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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.