Infection, BacterialPhase 1/2NCT03009734
Evaluation of ATx201 as a Topical Antibiotic Agent
A Phase 1/2 study testing ATx201 dermal formulations 2% in people with Infection, Bacterial, run by UNION therapeutics at 1 site in Austria.
Trial summary
AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- ATx201 dermal formulations 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2016to Mar 2018
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General inclusion criteria:
- Signed and dated informed consent has been obtained
- Age 18 - 70 years
- Male or female
- Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
- Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
Show all 36Show fewer
- Male subjects must agree to use adequate contraception for the duration of the trial
- Additional inclusion criteria for Phase II of the study:
- Localized disease (e.g. flexural eczema in a more or less symmetrical distribution on arms) where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigators global assessment score between 1-3.
- Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment score between 1-3.
- Total localized disease not exceeding 20 % body surface area
- Colonization of lesions with S.aureus as determined by cultivation
- General exclusion criteria
- Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase I only) or physical examination
- Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication
- History of irritation to topical products
- Current acute or chronic disease unless considered clinically irrelevant by the Investigator
- Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
- Positive HIV serology or evidence of active hepatitis
- Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
- History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
- caffeine (>5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more cigarettes/week)
- abnormal or special diet (e.g. vegetarian diet)
- Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
- Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
- Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
- Participation in another clinical trial with an investigational day within 4 weeks before screening
- Additional exclusion criteria for Phase I of the study:
- Regular use of medications
- Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study
- Additional exclusion criteria for Phase II of the study:
- Treatment with antibiotics (systemic or topical) within the past 3 months and during the study
- Treatment with drugs that affect the immune system within the past 3 months and during the study
- Treatment with topical steroids and calcineurin inhibitors 1 week before and during the study treatment period
- Treatment with systemic steroids within the past month and during the study
- Use of disinfectant soaps within 1 week before screening and during the study treatment period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, General Hospital of Vienna
Vienna, 1090
About this study
Official title: A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent
AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.
Read the detailed description
Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity of or resistance towards the main topical antibiotics. Accordingly, the infections are either not effectively treated or harsher systemic antibiotics with side effects are needed.
Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms. ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the onset of de novo resistance compared to currently marketed antibiotics.
The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.
The primary objective is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with infected atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.
- Conditions
- Infection, Bacterial
- Being tested
- ATx201 dermal formulations 2%
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATx201 dermal formulations 2%Drug
Topical application of ATx201 dermal formulations 2%
| Study group | Role | What they receive |
|---|---|---|
| ATx201 (2% dermal formulation A) and Placebo | Other | Not described Receives: Drug: ATx201 dermal formulations 2% |
| ATx201 (2% dermal formulation B) and Placebo | Other | Not described Receives: Drug: ATx201 dermal formulations 2% |
| ATx201 (2% dermal formulation C) and Placebo | Other | Not described Receives: Drug: ATx201 dermal formulations 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of new topical formulations of ATx201
Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
Measured: 7 days
Secondary outcomes (4)
Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201.
Will be assessed by the investigators global assessment (IGA score):
0: Clear (no inflammatory signs)
- Almost clear (just perceptible erythema, just perceptible papulation/infiltration)
- Mild disease (mild erythema and mild papulation/infiltration)
- Moderate disease (moderate erythema, moderate papulation/infiltration)
- Severe disease (severe erythema, severe population/infiltration)
Measured: 4 and 7 days
Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion
Measured: 4 and 7 days
Local dermal tolerability at the sites of application
Will be assessed using the following dermal assessment score:
0 = no evidence of irritation,
- = minimal erythema, barely perceptible,
- = definite erythema, readily visible; minimal edema or minimal papular response,
- = erythema and papule,
- = definite edema,
- = erythema, edema, and papule,
- = vesicular eruption,
- = strong reaction spreading beyond test site.
Measured: 7 days
Safety and tolerability of new topical formulations of ATx201
Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
Measured: 4 and 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNION therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Zeitlinger, MD, Principal investigator, General Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009734
- Sponsor's protocol ID
- DECOLAD
- Status last verified
- Mar 2018
- First submitted
- 22 Dec 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent
- ClinicalTrials.gov ID
- NCT03009734
- Acronym / sponsor ID
- DECOLAD
- Conditions
- Infection, Bacterial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- UNION therapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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.
AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.
Detailed description
Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity of or resistance towards the main topical antibiotics. Accordingly, the infections are either not effectively treated or harsher systemic antibiotics with side effects are needed.
Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms. ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the onset of de novo resistance compared to currently marketed antibiotics.
The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.
The primary objective is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with infected atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATx201 (2% dermal formulation A) and Placebo | Other | Drug: ATx201 dermal formulations 2% |
| ATx201 (2% dermal formulation B) and Placebo | Other | Drug: ATx201 dermal formulations 2% |
| ATx201 (2% dermal formulation C) and Placebo | Other | Drug: ATx201 dermal formulations 2% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Signed and dated informed consent has been obtained
- Age 18 - 70 years
- Male or female
- Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
- Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ATx201 dermal formulations 2%Topical application of ATx201 dermal formulations 2% | Drug | ATx201 (2% dermal formulation A) and Placebo, ATx201 (2% dermal formulation B) and Placebo, ATx201 (2% dermal formulation C) and Placebo |
Primary outcome
Safety and tolerability of new topical formulations of ATx201
Time frame: 7 days
Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class. The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
4 secondary outcomes
Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201.
Time frame: 4 and 7 days
Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion
Time frame: 4 and 7 days
Local dermal tolerability at the sites of application
Time frame: 7 days
Safety and tolerability of new topical formulations of ATx201
Time frame: 4 and 15 days
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 20 Mar 2018.
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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.
Markus Zeitlinger, MD principal investigator
General Hospital Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATx201 dermal formulations 2% in people with Infection, Bacterial, run by UNION therapeutics at 1 site in Austria.
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 36 inclusion and 0 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability of new topical formulations of ATx201 (time frame: 7 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 20 Mar 2018.