Trial · NCT01025635
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
NCT01025635, Phase 2, Completed, LEO Pharma; results first posted 2013-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea. Trials, record NCT01025635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01025635
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
- NCT number
- NCT01025635
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 401 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Papulopustular Rosacea
- Interventions
- Azelaic acid foam 15%, Vehicle foam
- First posted
- 2009-12-03
- Last updated
- 2020-03-31
- Results first posted
- 2013-07-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) | At End of treatment (up to 12 weeks) (LOCF) | The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal. |
| Primary | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Baseline and End of treatment (up to 12 weeks) (LOCF) | |
| Secondary | Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | At End of treatment (up to 12 weeks) (LOCF) | |
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) | At End of treatment (up to 12 weeks) (LOCF) | The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) | At End of treatment (up to 12 weeks) (LOCF) | Percentage of participants | NUMBER | |
| PRIMARY | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Baseline and End of treatment (up to 12 weeks) (LOCF) | Inflammatory lesions | MEAN | |
| SECONDARY | Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | At End of treatment (up to 12 weeks) (LOCF) | Percentage of Inflammatory lesions | MEAN | |
| SECONDARY | Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) | At End of treatment (up to 12 weeks) (LOCF) | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) | Azelaic Acid Foam, 15% (BAY39-6251) | 43.4 | Percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) | Vehicle Foam | 32.5 | Percentage of participants | ||
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | -13.4 | Standard Deviation 10.39 | Inflammatory lesions | |
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Vehicle Foam | -9.5 | Standard Deviation 9.73 | Inflammatory lesions | |
| Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | -62.5 | Standard Deviation 35.66 | Percentage of Inflammatory lesions | |
| Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) | Vehicle Foam | -47.8 | Standard Deviation 41.28 | Percentage of Inflammatory lesions | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | 69.2 | Percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) | Vehicle Foam | 57.6 | 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 | Azelaic Acid Foam, 15% (BAY39-6251) | 198 | |
| Overall Study | STARTED | Vehicle Foam | 203 | |
| Overall Study | COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 175 | |
| Overall Study | COMPLETED | Vehicle Foam | 178 | |
| Overall Study | NOT COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 23 | |
| Overall Study | NOT COMPLETED | Vehicle Foam | 25 |
Source ClinicalTrials.gov
Adverse events192
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 | Vertigo | Ear and labyrinth disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 198 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Vehicle Foam | 0 | 203 | 0 |
| other | Hypothyroidism | Endocrine disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 0 | 198 | 0 |
| other | Hypothyroidism | Endocrine disorders | Vehicle Foam | 1 | 203 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 198 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Vehicle Foam | 0 | 203 | 0 |
| other | Constipation | Gastrointestinal disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 198 | 1 |
| other | Constipation | Gastrointestinal disorders | Vehicle Foam | 0 | 203 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 2 | 198 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Vehicle Foam | 0 | 203 | 0 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 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) | 68 | 198 |
| Total, other adverse events | Vehicle Foam | 48 | 203 |
| Total, serious adverse events | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 198 |
| Total, serious adverse events | Vehicle Foam | 3 | 203 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24416747 | BACKGROUND |
Source PubMed
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/NCT01025635
GET https://conductscience.org/api/trials/v1/NCT01025635/events?page=2