Trial · NCT02090764
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
NCT02090764, Phase 3, Completed, Ferrer Internacional S.A.; results first posted 2016-05-19
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 NCT02090764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02090764
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
- NCT02090764
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 412 participants, actual
- Lead sponsor
- Ferrer Internacional S.A.
- Conditions
- Impetigo
- Interventions
- Ozenoxacin, Placebo
- First posted
- 2014-03-18
- Last updated
- 2024-08-20
- Results first posted
- 2016-05-19
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 | Visit 3 (Day 6-7) | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain. |
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 | Visit 3 (Day 6-7) | Intent-to-treat clinical (ITTC) population was defined as all randomized patients.~The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199) | percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Success | Ozenoxacin | 55.2 | percentage of Participants | ||
| Clinical Success | Placebo | 39.2 | percentage of Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ozenoxacin | 206 | |
| Overall Study | STARTED | Placebo | 206 | |
| Overall Study | COMPLETED | Ozenoxacin | 200 | |
| Overall Study | COMPLETED | Placebo | 186 | |
| Overall Study | NOT COMPLETED | Ozenoxacin | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 20 |
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ozenoxacin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ozenoxacin | 0 | 206 |
| Total, other adverse events | Placebo | 0 | 205 |
| Total, serious adverse events | Ozenoxacin | 0 | 206 |
| Total, serious adverse events | Placebo | 0 | 205 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ozenoxacin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT02090764
GET https://conductscience.org/api/trials/v1/NCT02090764/registered