ImpetigoPhase 2NCT00626795
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
A Phase 2 study testing TD1414 2% cream and Bactroban® (mupirocin) 2% cream in people with Impetigo and Secondarily Infected Traumatic Lesions, run by LEO Pharma at 2 sites in 2 countries.
Trial summary
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Impetigo, Secondarily Infected Traumatic Lesions
- What is being tested?
- TD1414 2% cream and Bactroban® (mupirocin) 2% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
- Outpatients of any sex or ethnic origin
- Patients >= 2 years of age (depending on study step)
- Patients must be suffering from primary bullous/non-bullous impetigo or SITL
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 burnwound
Show all 12Show fewer
- Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
- Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
- Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
- 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 randomisation
- Patients previously enrolled/randomised in this study
- Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Division of Dermatology, Groote Schuur Hospital, G23
Cape Town, Western Cape, 7925
About this study
Official title: Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
- Conditions
- Impetigo, Secondarily Infected Traumatic Lesions
- Being tested
- TD1414 2% cream, Bactroban® (mupirocin) 2% cream
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD1414 2% creamDrug
BID 7 days
TD1414 2% creamDrug
TID 7 days
Bactroban® (mupirocin) 2% creamDrug
BID 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: TD1414 2% cream |
| 2 | Experimental | Not described Receives: Drug: TD1414 2% cream |
| 3 | Active comparator | Not described Receives: Drug: Bactroban® (mupirocin) 2% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Clinical Cure According to Investigator's Assessment
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.
Investigator's assessment of severity of infections (SIRS).
- Exudates/pus
- Crusting
- Erythema
- Oedema
- Tissue Warmth
- Itching
- Pain
Each sign/symptoms of infection was assessed by use of the following 4-point scale:
- 0 = absent
- 2 = mild
- 4 = moderate
- 6 = severe
The scores were summed up to a total SIRS score.
Clinical cure was either of the following:
- Total absence of signs and symptoms of impetigo/SITL OR
- Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.
Clinical failure was either of the following:
- Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure
- Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
Measured: At end of treatment (Day 8)
Secondary outcomes (5)
Participants With Clinical Cure According to Investigator's Assessment
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Measured: At follow up (Day 15)
Participants With Clinical Cure According to Investigator's Assessment.
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Measured: At end of treatment (Day 8) and follow-up (Day 15)
Participants With Bacteriological Cure According to Bacteriological Samples
At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.
Bacteriological cure was either of the following:
- Eradication of the baseline pathogen.
- Presumed eradication of the baseline pathogen
- Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.
Bacteriological failure was any of the following:
- Documented lack of eradication of the baseline pathogen.
- Documented relapse (re-infection) with the baseline pathogen
- Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic
- Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.
Measured: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.
At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.
Measured: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical Cure According to Investigator's Assessment
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
Measured: At Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Almena L Free, MD, Principal investigator, Anniston Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626795
- Sponsor's protocol ID
- TD1414-C21
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2008
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
- ClinicalTrials.gov ID
- NCT00626795
- Acronym / sponsor ID
- TD1414-C21
- Conditions
- Impetigo, Secondarily Infected Traumatic Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TD1414 2% cream |
| 2 | Experimental | Drug: TD1414 2% cream |
| 3 | Active comparator | Drug: Bactroban® (mupirocin) 2% cream |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
- Outpatients of any sex or ethnic origin
- Patients >= 2 years of age (depending on study step)
- Patients must be suffering from primary bullous/non-bullous impetigo or SITL
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 |
|---|---|---|
| TD1414 2% creamBID 7 days | Drug | 1 |
| TD1414 2% creamTID 7 days | Drug | 2 |
| Bactroban® (mupirocin) 2% creamBID 7 days | Drug | 3 |
Primary outcome
Participants With Clinical Cure According to Investigator's Assessment
Time frame: At end of treatment (Day 8)
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: * Total absence of signs and symptoms of impetigo/SITL OR * Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: * Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure * Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
5 secondary outcomes
Participants With Clinical Cure According to Investigator's Assessment
Time frame: At follow up (Day 15)
Participants With Clinical Cure According to Investigator's Assessment.
Time frame: At end of treatment (Day 8) and follow-up (Day 15)
Participants With Bacteriological Cure According to Bacteriological Samples
Time frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Time frame: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up
Participants With Clinical Cure According to Investigator's Assessment
Time frame: At Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Almena L Free, MD principal investigator
Anniston Medical Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD1414 2% cream and Bactroban® (mupirocin) 2% cream in people with Impetigo and Secondarily Infected Traumatic Lesions, run by LEO Pharma at 2 sites in 2 countries.
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 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 12 Mar 2025. 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 United States, 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. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Clinical Cure According to Investigator's Assessment (time frame: At end of treatment (Day 8)). 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 12 Mar 2025.