Trial · NCT00617903
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
NCT00617903, Phase 2, Completed, LEO Pharma; results first posted 2013-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea. Trials, record NCT00617903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
- NCT number
- NCT00617903
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Papulopustular Rosacea
- Interventions
- Azelaic acid, Vehicle foam
- First posted
- 2008-02-18
- Last updated
- 2020-04-07
- Results first posted
- 2013-07-04
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | Baseline and End of Study (Week 12) | |
| Primary | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | At End of Study (Week 12) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Primary | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Baseline and End of Study (Week 12) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
| Secondary | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | |
| Secondary | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | |
| Secondary | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Secondary | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Secondary | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
| Secondary | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | Baseline and End of Study (Week 12) | Inflammatory lesions | MEAN | |
| PRIMARY | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | At End of Study (Week 12) | Percentage of participants | NUMBER | |
| PRIMARY | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Baseline and End of Study (Week 12) | Percentage of participants | NUMBER | |
| SECONDARY | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Inflammatory lesions | MEAN | |
| SECONDARY | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | Inflammatory lesions | MEAN | |
| SECONDARY | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Percent change in Inflammatory lesions | MEAN | |
| SECONDARY | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Scores on a scale | MEAN | |
| SECONDARY | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Scores on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group262
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | Azelaic Acid Foam, 15% (BAY39-6251) | -11.7 | Standard Deviation 8.53 | Inflammatory lesions | |
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | Vehicle Foam | -10.8 | Standard Deviation 7.80 | Inflammatory lesions | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | 46.3 | Percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | Vehicle Foam | 47.6 | Percentage of participants | ||
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | Improved | 61.0 | Percentage of participants | |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Vehicle Foam | Improved | 47.6 | Percentage of participants | |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | No change | 36.6 | Percentage of participants | |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Vehicle Foam | No change | 45.2 | Percentage of participants | |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | Worse | 2.4 | Percentage of participants | |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Vehicle Foam | Worse | 7.1 | Percentage of participants |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azelaic Acid Foam, 15% (BAY39-6251) | 41 | |
| Overall Study | STARTED | Vehicle Foam | 42 | |
| Overall Study | COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 38 | |
| Overall Study | COMPLETED | Vehicle Foam | 35 | |
| Overall Study | NOT COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 3 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 7 |
Source ClinicalTrials.gov
Adverse events42
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 | Conjunctivitis | Eye disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 41 | 1 |
| other | Conjunctivitis | Eye disorders | Vehicle Foam | 0 | 42 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 0 | 41 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Vehicle Foam | 1 | 42 | 1 |
| other | Administration site reaction | General disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 2 | 41 | 2 |
| other | Administration site reaction | General disorders | Vehicle Foam | 0 | 42 | 0 |
| other | Application site irritation | General disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 4 | 41 | 4 |
| other | Application site irritation | General disorders | Vehicle Foam | 1 | 42 | 1 |
| other | Infection | Infections and infestations | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 41 | 1 |
| other | Infection | Infections and infestations | Vehicle Foam | 0 | 42 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azelaic Acid Foam, 15% (BAY39-6251) | ||
| Total, all-cause mortality | Vehicle Foam | ||
| Total, other adverse events | Azelaic Acid Foam, 15% (BAY39-6251) | 14 | 41 |
| Total, other adverse events | Vehicle Foam | 10 | 42 |
| Total, serious adverse events | Azelaic Acid Foam, 15% (BAY39-6251) | 0 | 41 |
| Total, serious adverse events | Vehicle Foam | 0 | 42 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azelaic Acid Foam, 15% (BAY39-6251) vs Vehicle Foam: 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/NCT00617903
GET https://conductscience.org/api/trials/v1/NCT00617903/results?page=2