Trial · NCT00626795

Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

NCT00626795, Phase 2, Completed, LEO Pharma; results first posted 2018-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL). Trials, record NCT00626795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626795

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
NCT number: NCT00626795
Status: Completed
Phases: Phase 2
Enrollment: 773 participants, actual
Lead sponsor: LEO Pharma
Conditions: Impetigo, Secondarily Infected Traumatic Lesions
Interventions: TD1414 2% cream, TD1414 2% cream, Bactroban® (mupirocin) 2% cream
First posted: 2008-02-29
Last updated: 2025-03-12
Results first posted: 2018-07-23

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Clinical Cure According to Investigator's Assessment	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).
Secondary	Participants With Clinical Cure According to Investigator's Assessment	At follow up (Day 15)	At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Secondary	Participants With Clinical Cure According to Investigator's Assessment.	At end of treatment (Day 8) and follow-up (Day 15)	At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Secondary	Participants With Bacteriological Cure According to Bacteriological Samples	At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up	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.
Secondary	Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples	At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up	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.
Secondary	Participants With Clinical Cure According to Investigator's Assessment	At Day 4	At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Clinical Cure According to Investigator's Assessment	At end of treatment (Day 8)	All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Clinical Cure According to Investigator's Assessment	At follow up (Day 15)	All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Clinical Cure According to Investigator's Assessment.	At end of treatment (Day 8) and follow-up (Day 15)	All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Bacteriological Cure According to Bacteriological Samples	At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up	Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples	At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up	All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Clinical Cure According to Investigator's Assessment	At Day 4	All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Clinical Cure According to Investigator's Assessment	TD1414 BID	Clinical cure	167	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 TID	Clinical cure	184	Participants
Participants With Clinical Cure According to Investigator's Assessment	Bactroban® TID	Clinical cure	174	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 BID	Clinical failure	36	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 TID	Clinical failure	21	Participants
Participants With Clinical Cure According to Investigator's Assessment	Bactroban® TID	Clinical failure	30	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 BID	Clinical cure	173	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 TID	Clinical cure	188	Participants
Participants With Clinical Cure According to Investigator's Assessment	Bactroban® TID	Clinical cure	185	Participants
Participants With Clinical Cure According to Investigator's Assessment	TD1414 BID	Clinical failure	30	Participants

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open-label TD1414 Cream TID Treatment	STARTED	TD1414 BID	0
Open-label TD1414 Cream TID Treatment	STARTED	TD1414 TID	65
Open-label TD1414 Cream TID Treatment	STARTED	Bactroban® TID	0
Open-label TD1414 Cream TID Treatment	COMPLETED	TD1414 BID	0
Open-label TD1414 Cream TID Treatment	COMPLETED	TD1414 TID	64
Open-label TD1414 Cream TID Treatment	COMPLETED	Bactroban® TID	0
Open-label TD1414 Cream TID Treatment	NOT COMPLETED	TD1414 BID	0
Open-label TD1414 Cream TID Treatment	NOT COMPLETED	TD1414 TID	1
Open-label TD1414 Cream TID Treatment	NOT COMPLETED	Bactroban® TID	0
Blinded Treatment	STARTED	TD1414 BID	204

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events616

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 TID >=16 Years	0	17
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 TID >=12 to <16 Years	0	16
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 TID >=6 to <12 Years	0	16
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 TID >=2 to <6 Years	0	16
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 BID	0	203
other	Lymphadenopathy	Blood and lymphatic system disorders	TD1414 TID	2	205
other	Lymphadenopathy	Blood and lymphatic system disorders	Bactroban® TID	0	204
other	Aneamia	Blood and lymphatic system disorders	TD1414 TID >=16 Years	0	17
other	Aneamia	Blood and lymphatic system disorders	TD1414 TID >=12 to <16 Years	0	16
other	Aneamia	Blood and lymphatic system disorders	TD1414 TID >=6 to <12 Years	0	16

1 to 10 of 616Source ClinicalTrials.gov

See all 616 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TD1414 TID >=16 Years
Total, all-cause mortality	TD1414 TID >=12 to <16 Years
Total, all-cause mortality	TD1414 TID >=6 to <12 Years
Total, all-cause mortality	TD1414 TID >=2 to <6 Years
Total, all-cause mortality	TD1414 BID
Total, all-cause mortality	TD1414 TID
Total, all-cause mortality	Bactroban® TID
Total, other adverse events	TD1414 TID >=16 Years	6	17
Total, other adverse events	TD1414 TID >=12 to <16 Years	5	16
Total, other adverse events	TD1414 TID >=6 to <12 Years	2	16

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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