Trial · NCT02120924
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
NCT02120924, Phase 3, Completed, Actavis Inc.; results first posted 2020-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea. Trials, record NCT02120924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02120924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
- NCT number
- NCT02120924
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,009 participants, actual
- Lead sponsor
- Actavis Inc.
- Conditions
- Rosacea
- Interventions
- Azelaic acid, Vehicle, Finacea
- First posted
- 2014-04-23
- Last updated
- 2020-06-02
- Results first posted
- 2020-06-02
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 From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. | Baseline to Week 12 | Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population. |
| Secondary | The Percentage of Subjects With a Clinical Response of "Success" at Week 12 Using Investigator Global Evaluation (IGE) | Baseline to 12 weeks | The secondary endpoint is the clinical response of "success" or "failure" at Week 12 on the IGE. Success is defined as an IGE score of 0 (clear) or 1 (almost clear). Any subject who is not considered to be a success will be considered to be a failure. Score-Grade-Definition 0 - Clear - No inflammatory lesions present; at most, mild erythema. 1. \- Almost Clear - Very mild erythema present. Very few small papules/pustules. 2. \- Mild - Mild erythema. Several small papules/pustules. 3. \- Moderate - Moderate erythema. Several small or large papules/pustules, and up to two nodules. 4. \- Severe - Severe erythema. Numerous small and/or large papules/pustules, up to several nodules. |
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 From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. | Baseline to Week 12 | Per protocol population | Percent change in lesion counts | MEAN |
| SECONDARY | The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Baseline to 12 weeks | Analysis of Treatment Success Based on IGE Score at Week 12 in PP Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. | Azelaic Acid, 15% Topical Gel | -66.96 | Standard Deviation 29.394 | Percent change in lesion counts | |
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. | Finacea® (Azelaic Acid) Gel, 15% | -68.62 | Standard Deviation 27.415 | Percent change in lesion counts | |
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. | Gel Vehicle | -38.64 | Standard Deviation 46.845 | Percent change in lesion counts | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Azelaic Acid, 15% Topical Gel | Success | 138 | Participants | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Finacea® (Azelaic Acid) Gel, 15% | Success | 117 | Participants | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Gel Vehicle | Success | 40 | Participants | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Azelaic Acid, 15% Topical Gel | Failure | 155 | Participants | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Finacea® (Azelaic Acid) Gel, 15% | Failure | 157 | Participants | |
| The Percentage of Subjects With a Clinical Response of Success at Week 12 Using Investigator Global Evaluation (IGE) | Gel Vehicle | Failure | 87 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azelaic Acid, 15% Topical Gel | 404 | |
| Overall Study | STARTED | Finacea® (Azelaic Acid) Gel, 15% (Intendis) | 403 | |
| Overall Study | STARTED | Gel Vehicle | 202 | |
| Overall Study | COMPLETED | Azelaic Acid, 15% Topical Gel | 362 | |
| Overall Study | COMPLETED | Finacea® (Azelaic Acid) Gel, 15% (Intendis) | 357 | |
| Overall Study | COMPLETED | Gel Vehicle | 173 | |
| Overall Study | NOT COMPLETED | Azelaic Acid, 15% Topical Gel | 42 | |
| Overall Study | NOT COMPLETED | Finacea® (Azelaic Acid) Gel, 15% (Intendis) | 46 | |
| Overall Study | NOT COMPLETED | Gel Vehicle | 29 |
Source ClinicalTrials.gov
Adverse events387
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 | Anaemia | Blood and lymphatic system disorders | Azelaic Acid, 15% Topical Gel | 0 | 390 | |
| other | Anaemia | Blood and lymphatic system disorders | Finacea® (Azelaic Acid) Gel, 15% | 1 | 386 | |
| other | Anaemia | Blood and lymphatic system disorders | Gel Vehicle | 0 | 190 | |
| other | Cardiac failure congestive | Cardiac disorders | Azelaic Acid, 15% Topical Gel | 1 | 390 | |
| other | Cardiac failure congestive | Cardiac disorders | Finacea® (Azelaic Acid) Gel, 15% | 0 | 386 | |
| other | Cardiac failure congestive | Cardiac disorders | Gel Vehicle | 0 | 190 | |
| other | Ear pain | Ear and labyrinth disorders | Azelaic Acid, 15% Topical Gel | 1 | 390 | |
| other | Ear pain | Ear and labyrinth disorders | Finacea® (Azelaic Acid) Gel, 15% | 0 | 386 | |
| other | Ear pain | Ear and labyrinth disorders | Gel Vehicle | 1 | 190 | |
| other | Vertigo | Ear and labyrinth disorders | Azelaic Acid, 15% Topical Gel | 1 | 390 |
1 to 10 of 387Source ClinicalTrials.gov
See all 387 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azelaic Acid, 15% Topical Gel | 1 | 390 |
| Total, all-cause mortality | Finacea® (Azelaic Acid) Gel, 15% | 0 | 386 |
| Total, all-cause mortality | Gel Vehicle | 0 | 190 |
| Total, other adverse events | Azelaic Acid, 15% Topical Gel | 109 | 390 |
| Total, other adverse events | Finacea® (Azelaic Acid) Gel, 15% | 98 | 386 |
| Total, other adverse events | Gel Vehicle | 47 | 190 |
| Total, serious adverse events | Azelaic Acid, 15% Topical Gel | 1 | 390 |
| Total, serious adverse events | Finacea® (Azelaic Acid) Gel, 15% | 0 | 386 |
| Total, serious adverse events | Gel Vehicle | 0 | 190 |
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 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/NCT02120924
GET https://conductscience.org/api/trials/v1/NCT02120924/events?page=2