ImpetigoPhase 2NCT01171326
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients
A Phase 2 study testing Topical Minocycline Foam FXFM244 in people with Impetigo, run by Vyne Therapeutics Inc. at 1 site in Israel.
Trial summary
Impetigo is a common, highly infectious skin disease caused by bacterial infection and characterized by crusting skin lesions. It is most common in children, particularly children in unhealthy living conditions. In adults, it may follow other skin disorders. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Impetigo
- What is being tested?
- Topical Minocycline Foam FXFM244
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Apr 2012
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo
- Patients 2 years of age or older, and in general good health
- Patients with no less than two lesions and no more than seven lesions, area 0.5x0.5cm.
- No known medical conditions that, in the Investigator's opinion could interfere with study participation
- Patient / Patient's guardian (in the case of children) willing and able to comply with all requirement of the protocol
- Patient / Patient's guardian willing and able to give written informed consent prior to participation in the study
Who cannot join
- Presence of skin diseases at or near the investigational area
- Immunosuppressed state or other serious systemic disease
- Signs and/or symptoms of systemic infection
- Presence of skin infection/disorder not amenable to topical antibacterial treatment only
- Presence of secondarily-infected animal/human bite
- Presence of secondarily infected burn wound
Show all 12Show fewer
- Topical or systemic use of medicinal or other products before or during the study (oral or topical antibiotics, oral or topical corticosteroids and immuno modulators); or other drugs, which in the Investigators opinion could confound the evaluation of the effect of the study drugs
- Known or suspected hypersensitivity to Minocycline or any of the excipients in the study medication
- Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomization
- Patients previously enrolled/randomized in this study
- Use of another investigational drug within 30 days prior to entry into this study.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-group, Double Blind, Clinical Trial, to Assess the Safety and Efficacy of Topically Applied FXFM244 Antibiotic Foam in the Treatment of Impetigo
Impetigo is a common, highly infectious skin disease caused by bacterial infection and characterized by crusting skin lesions. It is most common in children, particularly children in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which can also be isolated from impetigo lesions.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.
Read the detailed description
A randomized, parallel-group, double (Investigator, patient) blind, comparative dose range finding clinical trial.
The study will involve two treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% , in a blinded fashion. Patients will be treated twice daily for 7 days. Following the screening period and baseline visit, study subjects will return at days 3, 7 and 14. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
- Conditions
- Impetigo
- Being tested
- Topical Minocycline Foam FXFM244
- Keywords
- topical, minocycline, foam, phase II, impetigo
- Medical subject headings
- Impetigo, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Minocycline Foam FXFM244Drug
FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Minocycline Foam FXFM244 - 4% Receives: Drug: Topical Minocycline Foam FXFM244 |
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Minocycline Foam FXFM244 - 1% Receives: Drug: Topical Minocycline Foam FXFM244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in lesion count
Measured: 7 days
Secondary outcomes (1)
The severity of the overall impetigo condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for Investigator's Global Assessment and bacteriological testing.
Measured: Days 3, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionApr 2012
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171326
- Sponsor's protocol ID
- 005-10LND /FX2010-01
- Status last verified
- Dec 2010
- First submitted
- 27 Jul 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Double Blind, Clinical Trial, to Assess the Safety and Efficacy of Topically Applied FXFM244 Antibiotic Foam in the Treatment of Impetigo
- ClinicalTrials.gov ID
- NCT01171326
- Acronym / sponsor ID
- 005-10LND /FX2010-01
- Conditions
- Impetigo
- Keywords
- topical, minocycline, foam, phase II, impetigo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jul 2010 (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.
Impetigo is a common, highly infectious skin disease caused by bacterial infection and characterized by crusting skin lesions. It is most common in children, particularly children in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which can also be isolated from impetigo lesions.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.
Detailed description
A randomized, parallel-group, double (Investigator, patient) blind, comparative dose range finding clinical trial.
The study will involve two treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% , in a blinded fashion. Patients will be treated twice daily for 7 days. Following the screening period and baseline visit, study subjects will return at days 3, 7 and 14. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Drug: Topical Minocycline Foam FXFM244Minocycline Foam FXFM244 - 4% |
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Drug: Topical Minocycline Foam FXFM244Minocycline Foam FXFM244 - 1% |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo
- Patients 2 years of age or older, and in general good health
- Patients with no less than two lesions and no more than seven lesions, area 0.5x0.5cm.
- No known medical conditions that, in the Investigator's opinion could interfere with study participation
- Patient / Patient's guardian (in the case of children) willing and able to comply with all requirement of the protocol
Key exclusion criteria (12 listed)
- Presence of skin diseases at or near the investigational area
- Immunosuppressed state or other serious systemic disease
- Signs and/or symptoms of systemic infection
- Presence of skin infection/disorder not amenable to topical antibacterial treatment only
- Presence of secondarily-infected animal/human bite
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 |
|---|---|---|
| Topical Minocycline Foam FXFM244FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days | Drug | Topical Minocycline Foam FXFM244 - 1%, Topical Minocycline Foam FXFM244 - 4% |
Primary outcome
Decrease in lesion count
Time frame: 7 days
1 secondary outcome
The severity of the overall impetigo condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for Investigator's Global Assessment and bacteriological testing.
Time frame: Days 3, 7 and 14
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 10 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Minocycline Foam FXFM244 in people with Impetigo, run by Vyne Therapeutics Inc. at 1 site in Israel.
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 6 inclusion and 12 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 10 Dec 2013. 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 Israel. 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 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?
Decrease in lesion count (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 10 Dec 2013.