Trial · NCT01397461
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
NCT01397461, Phase 3, Completed, Ferrer Internacional S.A.; results first posted 2016-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo. Trials, record NCT01397461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01397461
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
- NCT number
- NCT01397461
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 465 participants, actual
- Lead sponsor
- Ferrer Internacional S.A.
- Conditions
- Impetigo
- Interventions
- ozenoxacin placebo, retapamulin 1% ointment, ozenoxacin 1% cream
- First posted
- 2011-07-19
- Last updated
- 2016-07-01
- Results first posted
- 2016-05-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Success | 2 weeks | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Success | 2 weeks | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Success | Ozenoxacin 1% Cream | 34.8 | percentage of participants | ||
| Clinical Success | Ozenoxacin Placebo | 19.2 | percentage of participants | ||
| Clinical Success | Retapamulin 1% Ointment | 37.7 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ozenoxacin 1% Cream | 155 | |
| Overall Study | STARTED | Ozenoxacin Placebo | 156 | |
| Overall Study | STARTED | Retapamulin 1% Ointment | 154 | |
| Overall Study | COMPLETED | Ozenoxacin 1% Cream | 153 | |
| Overall Study | COMPLETED | Ozenoxacin Placebo | 150 | |
| Overall Study | COMPLETED | Retapamulin 1% Ointment | 152 | |
| Overall Study | NOT COMPLETED | Ozenoxacin 1% Cream | 2 | |
| Overall Study | NOT COMPLETED | Ozenoxacin Placebo | 6 | |
| Overall Study | NOT COMPLETED | Retapamulin 1% Ointment | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ozenoxacin 1% Cream | ||
| Total, all-cause mortality | Ozenoxacin Placebo | ||
| Total, all-cause mortality | Retapamulin 1% Ointment | ||
| Total, other adverse events | Ozenoxacin 1% Cream | 0 | 156 |
| Total, other adverse events | Ozenoxacin Placebo | 0 | 156 |
| Total, other adverse events | Retapamulin 1% Ointment | 0 | 152 |
| Total, serious adverse events | Ozenoxacin 1% Cream | 0 | 156 |
| Total, serious adverse events | Ozenoxacin Placebo | 0 | 156 |
| Total, serious adverse events | Retapamulin 1% Ointment | 0 | 152 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30365584 | DERIVED |
Source PubMed
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.
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.
GET https://conductscience.org/api/trials/v1/NCT01397461
GET https://conductscience.org/api/trials/v1/NCT01397461/registered