Trial · NCT04155203
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
NCT04155203, Phase 3, Completed, Padagis LLC; results first posted 2022-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions. Trials, record NCT04155203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04155203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
- NCT number
- NCT04155203
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 657 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Secondarily Infected Traumatic Skin Lesions
- Interventions
- Mupirocin Calcium, Mupirocin Calcium, Vehicle
- First posted
- 2019-11-07
- Last updated
- 2022-11-03
- Results first posted
- 2022-11-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 18 days |
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 | Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | 18 days | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | Perrigo Active | 145 | Participants | ||
| Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | Reference Active | 169 | Participants | ||
| Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms) | Vehicle Control | 124 | 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 | Perrigo Active | 219 | |
| Overall Study | STARTED | Reference Active | 219 | |
| Overall Study | STARTED | Vehicle Control | 219 | |
| Overall Study | COMPLETED | Perrigo Active | 165 | |
| Overall Study | COMPLETED | Reference Active | 184 | |
| Overall Study | COMPLETED | Vehicle Control | 165 | |
| Overall Study | NOT COMPLETED | Perrigo Active | 54 | |
| Overall Study | NOT COMPLETED | Reference Active | 35 | |
| Overall Study | NOT COMPLETED | Vehicle Control | 54 |
Source ClinicalTrials.gov
Adverse events3
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 | Events |
|---|---|---|---|---|---|---|
| serious | cellulitis | Skin and subcutaneous tissue disorders | Perrigo Active | 0 | 219 | 0 |
| serious | cellulitis | Skin and subcutaneous tissue disorders | Reference Active | 1 | 219 | 1 |
| serious | cellulitis | Skin and subcutaneous tissue disorders | Vehicle Control | 0 | 219 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perrigo Active | 0 | 219 |
| Total, all-cause mortality | Reference Active | 0 | 219 |
| Total, all-cause mortality | Vehicle Control | 0 | 219 |
| Total, other adverse events | Perrigo Active | 0 | 219 |
| Total, other adverse events | Reference Active | 0 | 219 |
| Total, other adverse events | Vehicle Control | 0 | 219 |
| Total, serious adverse events | Perrigo Active | 0 | 219 |
| Total, serious adverse events | Reference Active | 1 | 219 |
| Total, serious adverse events | Vehicle Control | 0 | 219 |
Source ClinicalTrials.gov
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.
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/NCT04155203
GET https://conductscience.org/api/trials/v1/NCT04155203/registered