ClinicalTrials.gg
CompletedNCT03429595Updated Jul 31, 2018

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

A Phase 2 interventional study of ATx201 and ATx201 GEL Vehicle in Impetigo, sponsored by UNION therapeutics. Completed at 16 sites in South Africa. Open to participants aged 9 Months to 70 Years. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by UNION therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
9 Months to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Impetigo

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03

In context

Impetigo

30 studies on the registry are indexed under Impetigo; 3 are open to participants now.

This study's enrollment of 210 is below the median of 255 across 24 interventional studies indexed under Impetigo.

Browse Impetigo studies →

Lead sponsor

UNION therapeutics is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    Group 1: ATx201 GEL 2%

    Drug: ATx201

  • Experimental
    Group 2: ATx201 GEL 4%

    Drug: ATx201

  • Experimental
    Group 3: ATx201 GEL 4% plus vehicle

    Drug: ATx201 · Other: ATx201 GEL Vehicle

  • Experimental
    Group 4: ATx201 GEL 4% plus vehicle

    Drug: ATx201 · Other: ATx201 GEL Vehicle

  • Placebo comparator
    Group 5: Vehicle

    Other: ATx201 GEL Vehicle

Interventions

  • DrugATx201

    ATx201 GEL

  • OtherATx201 GEL Vehicle

    Vehicle

06

What researchers measure

Primary outcomes

  1. Incidences of Adverse Events and Laboratory Parameters

    incidences of adverse events reports and changes in significant laboratory parameters

    Time frame: 14 days

07

Study locations

16 sites
  • AntibioTx Investigational Site
    Bloemfontein, South Africa
  • AntibioTx Investigative Site
    Boksburg, South Africa
  • AntibioTx Investigative Site
    Brandfort, South Africa
  • AntibioTx Investigative Site
    Claremont, South Africa
  • AntibioTx Investigative Site
    Durban, South Africa
  • AntibioTx Investigative Site
    Germiston, South Africa
  • AntibioTx Investigative Site 2
    Johannesburg, South Africa
  • AntibioTx Investigative Site
    Johannesburg, South Africa
  • AntibioTx Investigative Site
    Kraaifontein, South Africa
  • AntibioTx Investigative Site
    Mpumalanga, South Africa
  • AntibioTx Investigative Site
    Paarl, South Africa
  • AntibioTx Investigative Site 2
    Port Elizabeth, South Africa
  • AntibioTx Investigative Site
    Port Elizabeth, South Africa
  • AntibioTx Investigative Site
    Pretoria, South Africa
  • AntibioTx Investigative Site
    Soshanguve, South Africa
  • AntibioTx Investigative Site
    Umkomaas, South Africa
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03429595
Lead sponsor
UNION therapeutics
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Feb 23, 2018
Primary completion
Jun 26, 2018
Completion
Jun 26, 2018
Last update
Jul 31, 2018

Study contacts

Philippe Prokocimer, MD
study director · CMO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ATX201

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