Trial · NCT01555463
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
NCT01555463, Phase 3, Completed, LEO Pharma; results first posted 2015-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea. Trials, record NCT01555463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01555463
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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
- NCT01555463
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 961 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Papulopustular Rosacea
- Interventions
- Azelaic acid foam, 15% (BAY39-6251), Vehicle foam
- First posted
- 2012-03-15
- Last updated
- 2023-06-09
- Results first posted
- 2015-01-27
Source ClinicalTrials.gov
Registered outcomes18
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 (LOCF), up to 12 weeks | Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous 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 at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided. |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided. |
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented. |
| Secondary | Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented. |
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided. |
| Secondary | Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | The mean (standard deviation) lesion count at the end of treatment is provided. |
| Secondary | Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided. |
| Secondary | Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented. |
| Secondary | Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| PRIMARY | Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Inflammatory lesions | MEAN |
| SECONDARY | Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percent change of inflammatory lesions | MEAN |
| SECONDARY | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| SECONDARY | Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| SECONDARY | Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Inflammatory lesions | MEAN |
| SECONDARY | Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| SECONDARY | Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF) | Baseline and end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF) | At end of treatment (LOCF), up to 12 weeks | All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline. | Percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group102
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) | 32.1 | 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 | 23.4 | Percentage of participants | ||
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | -13.2 | Standard Deviation 9.5 | Inflammatory lesions | |
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF) | Vehicle Foam | -10.3 | Standard Deviation 9.8 | Inflammatory lesions | |
| Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | -61.6 | Standard Deviation 33.5 | Percent change of inflammatory lesions | |
| Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF) | Vehicle Foam | -50.8 | Standard Deviation 40.0 | Percent change of inflammatory lesions | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | 66.3 | Percentage of participants | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF) | Vehicle Foam | 54.4 | Percentage of participants | ||
| Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF) | Azelaic Acid Foam, 15% (BAY39-6251) | Improved | 61.5 | Percentage of participants | |
| Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF) | Vehicle Foam | Improved | 51.3 | Percentage of participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Azelaic Acid Foam, 15% (BAY39-6251) | 483 | |
| Treatment | STARTED | Vehicle Foam | 478 | |
| Treatment | COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 419 | |
| Treatment | COMPLETED | Vehicle Foam | 399 | |
| Treatment | NOT COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 64 | |
| Treatment | NOT COMPLETED | Vehicle Foam | 79 | |
| Follow up | STARTED | Azelaic Acid Foam, 15% (BAY39-6251) | 447 | |
| Follow up | STARTED | Vehicle Foam | 439 | |
| Follow up | COMPLETED | Azelaic Acid Foam, 15% (BAY39-6251) | 409 | |
| Follow up | COMPLETED | Vehicle Foam | 394 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events314
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 | Lymph node pain | Blood and lymphatic system disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 483 | 1 |
| other | Lymph node pain | Blood and lymphatic system disorders | Vehicle Foam | 0 | 478 | 0 |
| other | Tachycardia | Cardiac disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 483 | 1 |
| other | Tachycardia | Cardiac disorders | Vehicle Foam | 0 | 478 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 483 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Vehicle Foam | 0 | 478 | 0 |
| other | Hypothyroidism | Endocrine disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 483 | 1 |
| other | Hypothyroidism | Endocrine disorders | Vehicle Foam | 0 | 478 | 0 |
| other | Conjunctival hyperaemia | Eye disorders | Azelaic Acid Foam, 15% (BAY39-6251) | 1 | 483 | 1 |
| other | Conjunctival hyperaemia | Eye disorders | Vehicle Foam | 0 | 478 | 0 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 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) | 148 | 483 |
| Total, other adverse events | Vehicle Foam | 117 | 478 |
| Total, serious adverse events | Azelaic Acid Foam, 15% (BAY39-6251) | 3 | 483 |
| Total, serious adverse events | Vehicle Foam | 4 | 478 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26244354 | RESULT |
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.
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