ImpetigoPhase 2NCT03429595
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
A Phase 2 study testing ATx201 in people with Impetigo, run by UNION therapeutics at 16 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 months to 70 years
- Conditions the study is for
- Impetigo
- What is being tested?
- ATx201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 16 sitesSouth Africa
- Study dates
- 23 Feb 2018to 26 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Africa16 sites
AntibioTx Investigational Site
Bloemfontein
AntibioTx Investigative Site
Boksburg
AntibioTx Investigative Site
Claremont
AntibioTx Investigative Site
Durban
AntibioTx Investigative Site
eMkhomazi
AntibioTx Investigative Site
Germiston
AntibioTx Investigative Site 2
Johannesburg
AntibioTx Investigative Site
Johannesburg
AntibioTx Investigative Site
Kraaifontein
AntibioTx Investigative Site
Mpumalanga
AntibioTx Investigative Site
Paarl
AntibioTx Investigative Site 2
Port Elizabeth
AntibioTx Investigative Site
Port Elizabeth
AntibioTx Investigative Site
Pretoria
AntibioTx Investigative Site
Soshanguve
AntibioTx Investigative Site
Winnie Mandela
About this study
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
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.
- Conditions
- Impetigo
- Being tested
- ATx201, ATx201 GEL Vehicle
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201Drug
ATx201 GEL
ATx201 GEL VehicleOther
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ATx201 GEL 2% | Experimental | Not described Receives: Drug: ATx201 |
| Group 2: ATx201 GEL 4% | Experimental | Not described Receives: Drug: ATx201 |
| Group 3: ATx201 GEL 4% plus vehicle | Experimental | Not described Receives: Drug: ATx201; Other: ATx201 GEL Vehicle |
| Group 4: ATx201 GEL 4% plus vehicle | Experimental | Not described Receives: Drug: ATx201; Other: ATx201 GEL Vehicle |
| Group 5: Vehicle | Placebo comparator | Not described Receives: Other: ATx201 GEL Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Adverse Events and Laboratory Parameters
incidences of adverse events reports and changes in significant laboratory parameters
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 Feb 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Prokocimer, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429595
- Sponsor's protocol ID
- ATx201-004
- Status last verified
- Jul 2018
- First submitted
- 6 Feb 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03429595
- Acronym / sponsor ID
- ATx201-004
- Conditions
- Impetigo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
| Arm | Type | Receives |
|---|---|---|
| Group 1: ATx201 GEL 2% | Experimental | Drug: ATx201 |
| Group 2: ATx201 GEL 4% | Experimental | Drug: ATx201 |
| Group 3: ATx201 GEL 4% plus vehicle | Experimental | Drug: ATx201, Other: ATx201 GEL Vehicle |
| Group 4: ATx201 GEL 4% plus vehicle | Experimental | Drug: ATx201, Other: ATx201 GEL Vehicle |
| Group 5: Vehicle | Placebo comparator | Other: ATx201 GEL Vehicle |
Who may qualify
- Ages
- 9 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATx201ATx201 GEL | Drug | Group 1: ATx201 GEL 2%, Group 2: ATx201 GEL 4%, Group 3: ATx201 GEL 4% plus vehicle, Group 4: ATx201 GEL 4% plus vehicle |
| ATx201 GEL VehicleVehicle | Other | Group 3: ATx201 GEL 4% plus vehicle, Group 4: ATx201 GEL 4% plus vehicle, Group 5: Vehicle |
Primary outcome
Incidences of Adverse Events and Laboratory Parameters
Time frame: 14 days
incidences of adverse events reports and changes in significant laboratory parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Impetigo
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
Not yet recruitingObservational study
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Prokocimer, MD study director
CMO
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATx201 in people with Impetigo, run by UNION therapeutics at 16 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Adverse Events and Laboratory Parameters (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.