Trial · NCT01493947
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
NCT01493947, Phase 3, Completed, Galderma R&D; results first posted 2015-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study. Trials, record NCT01493947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01493947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
- NCT number
- NCT01493947
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 962 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Papulopustular Rosacea
- Interventions
- Ivermectin 1% cream, Metronidazole 0.75% cream
- First posted
- 2011-12-16
- Last updated
- 2015-10-28
- Results first posted
- 2015-10-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Inflammatory Lesions From Baseline to Week 16 | Baseline and Week 16 | Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period |
| Other | Time to Relapse | Week 16 up to Week 52 | Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Inflammatory Lesions From Baseline to Week 16 | Baseline and Week 16 | percentage of change | MEAN | |
| OTHER_PRE_SPECIFIED | Time to Relapse | Week 16 up to Week 52 | Median days to relapse | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Inflammatory Lesions From Baseline to Week 16 | Ivermectin | -83 | Standard Deviation 26 | percentage of change | |
| Percent Change in Inflammatory Lesions From Baseline to Week 16 | Metronidazole 0.75% Cream | -73.7 | Standard Deviation 39.7 | percentage of change | |
| Time to Relapse | CD5024 | 115 | 95% Confidence Interval 113 to 165 | Median days to relapse | |
| Time to Relapse | Metronidazole 0.75% Cream | 85 | 95% Confidence Interval 85 to 113 | Median days to relapse |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period A Efficacy and Safety Data | STARTED | Ivermectin | 478 | |
| Period A Efficacy and Safety Data | STARTED | Metronidazole 0.75% Cream | 484 | |
| Period A Efficacy and Safety Data | COMPLETED | Ivermectin | 446 | |
| Period A Efficacy and Safety Data | COMPLETED | Metronidazole 0.75% Cream | 456 | |
| Period A Efficacy and Safety Data | NOT COMPLETED | Ivermectin | 32 | |
| Period A Efficacy and Safety Data | NOT COMPLETED | Metronidazole 0.75% Cream | 28 | |
| Period B Extension Period | STARTED | Ivermectin | 399 | |
| Period B Extension Period | STARTED | Metronidazole 0.75% Cream | 358 | |
| Period B Extension Period | COMPLETED | Ivermectin | 366 | |
| Period B Extension Period | COMPLETED | Metronidazole 0.75% Cream | 326 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events204
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 |
|---|---|---|---|---|---|---|
| other | Nasopharingitis | Infections and infestations | Ivermectin 1% Cream Period A | 32 | 478 | 32 |
| other | Nasopharingitis | Infections and infestations | Metronidazole 0.75% Cream Period A | 29 | 484 | 29 |
| other | Nasopharingitis | Infections and infestations | Ivermectin 1% Cream Period B | 37 | 399 | 37 |
| other | Nasopharingitis | Infections and infestations | Metronidazole 0.75% Cream Period B | 39 | 359 | 39 |
| other | Influenza | Infections and infestations | Ivermectin 1% Cream Period A | 9 | 478 | 9 |
| other | Influenza | Infections and infestations | Metronidazole 0.75% Cream Period A | 10 | 484 | 10 |
| other | Influenza | Infections and infestations | Ivermectin 1% Cream Period B | 12 | 399 | 12 |
| other | Influenza | Infections and infestations | Metronidazole 0.75% Cream Period B | 6 | 359 | 6 |
| other | Headache | Nervous system disorders | Ivermectin 1% Cream Period A | 15 | 478 | 15 |
| other | Headache | Nervous system disorders | Metronidazole 0.75% Cream Period A | 11 | 484 | 11 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivermectin 1% Cream Period A | ||
| Total, all-cause mortality | Metronidazole 0.75% Cream Period A | ||
| Total, all-cause mortality | Ivermectin 1% Cream Period B | ||
| Total, all-cause mortality | Metronidazole 0.75% Cream Period B | ||
| Total, other adverse events | Ivermectin 1% Cream Period A | 101 | 478 |
| Total, other adverse events | Metronidazole 0.75% Cream Period A | 100 | 484 |
| Total, other adverse events | Ivermectin 1% Cream Period B | 110 | 399 |
| Total, other adverse events | Metronidazole 0.75% Cream Period B | 91 | 359 |
| Total, serious adverse events | Ivermectin 1% Cream Period A | 8 | 478 |
| Total, serious adverse events | Metronidazole 0.75% Cream Period A | 5 | 484 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01493947
GET https://conductscience.org/api/trials/v1/NCT01493947/events?page=2