Non-bullous ImpetigoPhase 2NCT01803035
A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
A Phase 2 study testing LTX-109 1 % and LTX-109 2 % in people with Non-bullous Impetigo, run by Lytix Biopharma AS at 2 sites in Dominican Republic.
Trial summary
The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Non-bullous Impetigo
- What is being tested?
- LTX-109 1 % and LTX-109 2 %
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesDominican Republic
- Study dates
- Feb 2013to Apr 2014
- 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 ≥ 2 years of age.
- Signed written informed consent document by patient, parent, legal guardian or caretaker.
- Positive Gram-stain of target lesion showing Gram-positive cocci.
- Clinical diagnosis of primary non-bullous impetigo as per protocol.
- Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.
- Total lesion area ≤ 20 cm2. Single lesion not to exceed 2 cm2.
- No known medical conditions that in the investigators opinion may interfere with study participation or put the patient at additional risk.
Who cannot join
- Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.
- Presence of other skin disease at or near the investigational target area to be treated.
- The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.
- History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.
- Concurrent or recent scabies infection.
- Signs and symptoms of a current infection requiring antibiotic treatment.
Show all 13Show fewer
- Tympanic temperature at Baseline > 38 °C (100.4 °F) in a pediatric patient or 37.8 °C (100 °F) in an adult patient.
- Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry.
- Participation in any other clinical study or use of any other investigational drugs or investigational device within 30 days prior to treatment.
- Known allergy to any constituent of the study medication.
- Presence of secondarily-infected animal/human/insect bite or infected burn wound.
- Other reason which based on the discretion of the investigator makes the patient unsuitable for enrolment.
- Lactating or pregnant.
Trial locations and contacts
2 sites in 1 country.
Dominican Republic2 sites
Dr. Robert Reid Cabral Children Hospital
Santo Domingo
Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz
Santo Domingo
About this study
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 (1 % and 2 %) Versus Placebo in Impetigo
The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo.
Read the detailed description
The study will be a randomized, double-blind, placebo controlled study. Up to 210 patients will be enrolled to three treatment groups who will receive 1 % LTX-109, 2 % LTX-109 or placebo three times daily (TID) for 5 days. Patients will be randomized to receive LTX-109 or placebo at a ratio of 1:1 at each of the doses.
Patients ≥2 years with non-bullous impetigo will be enrolled in the study. Study candidacy will be determined by a dermatological examination, medical history, clinical diagnosis of non-bullous impetigo and a positive Gram-stain. Patients meeting eligibility will be randomized to one of the treatment groups.
A safety visit will be performed at Day 4. Clinical response will be evaluated by clinical success, clinical improvement or clinical failure according to definitions in the protocol at one or more of the visits - Day 4 (-1), Day 6 (+2) and Day 12 (+2), and will be derived from the Skin Infection Rating Scale (SIRS) score of the target lesion.
Bacteriological response will be evaluated by culture of swabs collected from the target lesion. Success or failure will be defined by presence or non-presence of the causative pathogen (bacteria isolated at baseline considered being the causative pathogen: S. aureus or S. pyogenes). Bacteriological swabs will be collected if pus/exudate is available at Day 4 (-1), Day 6 (+2) and Day 12 (+2), if there is exudate/pus available from the target lesion. No pus/exudate will be considered as elimination of the causative pathogen, and will be considered as bacteriological success.
- Conditions
- Non-bullous Impetigo
- Being tested
- LTX-109 1 %, LTX-109 2 %, Placebo gel
- Keywords
- Impetigo, LTX-109, Topical, Antibiotic, Placebo, Lytic, Peptide, Gram Positive
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-109 1 %Drug
LTX-109 2 %Drug
Placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 % LTX-109 | Experimental | LTX-109 topical gel in 1 % strength Receives: Drug: LTX-109 1 % |
| 2 % LTX-109 | Experimental | LTX-109 topical gel in 2 % strength Receives: Drug: LTX-109 2 % |
| Placebo | Placebo comparator | Placebo gel, containing all ingredients except LTX-109 Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of LTX-109.
Efficacy of two doses 1% and 2% LTX-109 versus placebo will be measured by clinical response.
Clinical response is defined as "Clinical success", "Clinical improvement" and "Clinical failure". Evaluation of the target lesion will be done at day 4, day 6 and day 12 and will be derived from Skin Infection Rating Scale (SIRS).
Measured: One year
Secondary outcomes (2)
Safety of topical administration in treatment of impetigo.
Safety will be monitored through physical examination, compliance with assigned treatment, and recording of adverse events occurring during the study period. Changes in clinical signs and symptoms will be recorded in the SIRS score. An assessment will be done of the target lesion and one overall assessment of the subject non-target lesions. A targeted physical examination will be done if any abnormalities occur.
For the study analysis the number of patients with adverse events and the nature of the adverse events will be listed per treatment group.
Measured: One year
Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo.
Microbiological response will be measured by "Bacteriological Success" or "Bacteriological failure". The response will be derived from bacterial swab cultures, and presence or non-presence of the causative pathogen at each of the follow up visits, day 4, day 6, and day 12.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-bullous 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lytix Biopharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daisy M Blanco, MD, Principal investigator, Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo DomingoJosefina Fernandez, MD, Principal investigator, Dr. Robert Reid Cabral Children hospital, Santo Domingo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803035
- Sponsor's protocol ID
- C12-109-04
- Status last verified
- Apr 2014
- First submitted
- 21 Feb 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 (1 % and 2 %) Versus Placebo in Impetigo
- ClinicalTrials.gov ID
- NCT01803035
- Acronym / sponsor ID
- C12-109-04
- Conditions
- Non-bullous Impetigo
- Keywords
- Impetigo, LTX-109, Topical, Antibiotic, Placebo, Lytic, Peptide, Gram Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Lytix Biopharma ASIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Mar 2013 (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.
The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo.
Detailed description
The study will be a randomized, double-blind, placebo controlled study. Up to 210 patients will be enrolled to three treatment groups who will receive 1 % LTX-109, 2 % LTX-109 or placebo three times daily (TID) for 5 days. Patients will be randomized to receive LTX-109 or placebo at a ratio of 1:1 at each of the doses.
Patients ≥2 years with non-bullous impetigo will be enrolled in the study. Study candidacy will be determined by a dermatological examination, medical history, clinical diagnosis of non-bullous impetigo and a positive Gram-stain. Patients meeting eligibility will be randomized to one of the treatment groups.
A safety visit will be performed at Day 4. Clinical response will be evaluated by clinical success, clinical improvement or clinical failure according to definitions in the protocol at one or more of the visits - Day 4 (-1), Day 6 (+2) and Day 12 (+2), and will be derived from the Skin Infection Rating Scale (SIRS) score of the target lesion.
Bacteriological response will be evaluated by culture of swabs collected from the target lesion. Success or failure will be defined by presence or non-presence of the causative pathogen (bacteria isolated at baseline considered being the causative pathogen: S. aureus or S. pyogenes). Bacteriological swabs will be collected if pus/exudate is available at Day 4 (-1), Day 6 (+2) and Day 12 (+2), if there is exudate/pus available from the target lesion. No pus/exudate will be considered as elimination of the causative pathogen, and will be considered as bacteriological success.
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 |
|---|---|---|
| 1 % LTX-109 | Experimental | Drug: LTX-109 1 %LTX-109 topical gel in 1 % strength |
| 2 % LTX-109 | Experimental | Drug: LTX-109 2 %LTX-109 topical gel in 2 % strength |
| Placebo | Placebo comparator | Drug: Placebo gelPlacebo gel, containing all ingredients except LTX-109 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 2 years of age.
- Signed written informed consent document by patient, parent, legal guardian or caretaker.
- Positive Gram-stain of target lesion showing Gram-positive cocci.
- Clinical diagnosis of primary non-bullous impetigo as per protocol.
- Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.
Key exclusion criteria (13 listed)
- Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.
- Presence of other skin disease at or near the investigational target area to be treated.
- The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.
- History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.
- Concurrent or recent scabies infection.
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 |
|---|---|---|
| LTX-109 1 % | Drug | 1 % LTX-109 |
| LTX-109 2 % | Drug | 2 % LTX-109 |
| Placebo gel | Drug | Placebo |
Primary outcome
Efficacy of LTX-109.
Time frame: One year
Efficacy of two doses 1% and 2% LTX-109 versus placebo will be measured by clinical response. Clinical response is defined as "Clinical success", "Clinical improvement" and "Clinical failure". Evaluation of the target lesion will be done at day 4, day 6 and day 12 and will be derived from Skin Infection Rating Scale (SIRS).
2 secondary outcomes
Safety of topical administration in treatment of impetigo.
Time frame: One year
Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo.
Time frame: One year
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 28 Apr 2014.
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.
Daisy M Blanco, MD principal investigator
Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo Domingo
Josefina Fernandez, MD principal investigator
Dr. Robert Reid Cabral Children hospital, Santo Domingo
2 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 LTX-109 1 % and LTX-109 2 % in people with Non-bullous Impetigo, run by Lytix Biopharma AS at 2 sites in Dominican Republic.
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 7 inclusion and 13 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Dominican Republic. 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?
Efficacy of LTX-109. (time frame: One year). 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 28 Apr 2014.