Trial · NCT01494467
Phase 3 Papulopustular Rosacea Study
NCT01494467, Phase 3, Completed, Galderma R&D; results first posted 2015-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Papulopustular Rosacea Study. Trials, record NCT01494467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494467
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Papulopustular Rosacea Study
- NCT number
- NCT01494467
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 688 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Papulopustular Rosacea
- Interventions
- CD5024, Azelaic acid 15% Gel
- First posted
- 2011-12-19
- Last updated
- 2021-02-18
- Results first posted
- 2015-01-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate | Week 12 | Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema) |
| Primary | Absolute Change in Inflammatory Lesion Count | Baseline to Week 12 | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
| Secondary | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | Baseline to Week 12 | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rate | Week 12 | LOCF, ITT | Percentage of participants | NUMBER |
| PRIMARY | Absolute Change in Inflammatory Lesion Count | Baseline to Week 12 | LOCF, ITT | Lesion count change | MEAN |
| SECONDARY | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | Baseline to Week 12 | Percentage of change in lesion counts | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate | CD5024 1% Cream | 40.1 | Percentage of participants | ||
| Success Rate | CD5024 Vehicle Cream | 18.8 | Percentage of participants | ||
| Absolute Change in Inflammatory Lesion Count | CD5024 1% Cream | -22.2 | Standard Deviation 14.87 | Lesion count change | |
| Absolute Change in Inflammatory Lesion Count | CD5024 Vehicle Cream | -13.4 | Standard Deviation 14.48 | Lesion count change | |
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | CD5024 1% Cream | -65.7 | Standard Deviation 33.18 | Percentage of change in lesion counts | |
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | CD5024 Vehicle Cream | -43.4 | Standard Deviation 38.42 | Percentage of change in lesion counts |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A Vehicle Control (12 Weeks) | STARTED | CD5024 1% Cream | 459 | |
| Part A Vehicle Control (12 Weeks) | STARTED | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | 229 | |
| Part A Vehicle Control (12 Weeks) | COMPLETED | CD5024 1% Cream | 429 | |
| Part A Vehicle Control (12 Weeks) | COMPLETED | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | 208 | |
| Part A Vehicle Control (12 Weeks) | NOT COMPLETED | CD5024 1% Cream | 30 | |
| Part A Vehicle Control (12 Weeks) | NOT COMPLETED | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | 21 | |
| Part B Long Term Active Control 40 Weeks | STARTED | CD5024 1% Cream | 428 | |
| Part B Long Term Active Control 40 Weeks | STARTED | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | 208 | |
| Part B Long Term Active Control 40 Weeks | COMPLETED | CD5024 1% Cream | 353 | |
| Part B Long Term Active Control 40 Weeks | COMPLETED | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | 159 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events320
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 | Nasopharyngitis | Infections and infestations | CD5024 1% Cream - Part A | 10 | 458 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 Vehicle Cream - Part A | 6 | 230 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 1% Cream - Part B | 43 | 428 | |
| other | Nasopharyngitis | Infections and infestations | Azelaic Acid 15% Gel - Part B | 18 | 208 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 1% Cream - Part C | 1 | 353 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | 1 | 159 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 1% Cream - Overall | 52 | 460 | |
| other | Nasopharyngitis | Infections and infestations | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | 23 | 231 | |
| other | Upper respiratory tract infection | Infections and infestations | CD5024 1% Cream - Part A | 12 | 458 | |
| other | Upper respiratory tract infection | Infections and infestations | CD5024 Vehicle Cream - Part A | 8 | 230 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD5024 1% Cream - Part A | ||
| Total, all-cause mortality | CD5024 Vehicle Cream - Part A | ||
| Total, all-cause mortality | CD5024 1% Cream - Part B | ||
| Total, all-cause mortality | Azelaic Acid 15% Gel - Part B | ||
| Total, all-cause mortality | CD5024 1% Cream - Part C | ||
| Total, all-cause mortality | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | ||
| Total, all-cause mortality | CD5024 1% Cream - Overall | ||
| Total, all-cause mortality | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | ||
| Total, other adverse events | CD5024 1% Cream - Part A | 33 | 458 |
| Total, other adverse events | CD5024 Vehicle Cream - Part A | 26 | 230 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT01494467
GET https://conductscience.org/api/trials/v1/NCT01494467/events?page=2