Trial · NCT03287791
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
NCT03287791, Phase 3, Completed, Actavis Inc.; results first posted 2019-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea. Trials, record NCT03287791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03287791
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
- NCT number
- NCT03287791
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 924 participants, actual
- Lead sponsor
- Actavis Inc.
- Conditions
- Rosacea
- Interventions
- Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam, Vehicle Foam, Cleanser, Sunscreen, Towel, Moisturizing Lotion
- First posted
- 2017-09-19
- Last updated
- 2019-07-31
- Results first posted
- 2019-07-17
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 in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 | Baseline, 12 weeks | All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion \>5 mm in diameter. |
| Secondary | Percentage of Participants With Treatment Success Based on IGE Score | Baseline and 12 Weeks | Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). |
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 in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 | Baseline, 12 weeks | Participants in the PP Population. If participant discontinued between 8 and 12 weeks of treatment due to lack of treatment, last observation carried forward (LOCF) was used to impute the number of lesions. If participant was missing Week 12 assessment for any other reason, participant was excluded. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Treatment Success Based on IGE Score | Baseline and 12 Weeks | Participants in the PP Population. Participants who did not have a valid Week 12 assessment for any other reason were excluded from the PP analysis. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 | Generic Azelaic Acid Foam | -64.28 | Standard Deviation 25.050 | percent change | |
| Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 | Finacea (Azelaic Acid) Foam | -65.15 | Standard Deviation 26.419 | percent change | |
| Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12 | Vehicle Foam | -57.84 | Standard Deviation 30.626 | percent change | |
| Percentage of Participants With Treatment Success Based on IGE Score | Generic Azelaic Acid Foam | 39.7 | percentage of participants | ||
| Percentage of Participants With Treatment Success Based on IGE Score | Finacea (Azelaic Acid) Foam | 48.3 | percentage of participants | ||
| Percentage of Participants With Treatment Success Based on IGE Score | Vehicle Foam | 33.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Generic Azelaic Acid Foam | 312 | |
| Overall Study | STARTED | Finacea (Azelaic Acid) Foam | 312 | |
| Overall Study | STARTED | Vehicle Foam | 300 | |
| Overall Study | Safety Population | Generic Azelaic Acid Foam | 306 | |
| Overall Study | Safety Population | Finacea (Azelaic Acid) Foam | 297 | |
| Overall Study | Safety Population | Vehicle Foam | 291 | |
| Overall Study | mITT Population | Generic Azelaic Acid Foam | 291 | |
| Overall Study | mITT Population | Finacea (Azelaic Acid) Foam | 291 | |
| Overall Study | mITT Population | Vehicle Foam | 283 | |
| Overall Study | PP Population | Generic Azelaic Acid Foam | 262 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events231
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 | Hypothyroidism | Endocrine disorders | Generic Azelaic Acid Foam | 0 | 306 | |
| other | Hypothyroidism | Endocrine disorders | Finacea (Azelaic Acid) Foam | 0 | 297 | |
| other | Hypothyroidism | Endocrine disorders | Vehicle Foam | 1 | 291 | |
| other | Dacryostenosis acquired | Eye disorders | Generic Azelaic Acid Foam | 1 | 306 | |
| other | Dacryostenosis acquired | Eye disorders | Finacea (Azelaic Acid) Foam | 0 | 297 | |
| other | Dacryostenosis acquired | Eye disorders | Vehicle Foam | 0 | 291 | |
| other | Eye swelling | Eye disorders | Generic Azelaic Acid Foam | 1 | 306 | |
| other | Eye swelling | Eye disorders | Finacea (Azelaic Acid) Foam | 0 | 297 | |
| other | Eye swelling | Eye disorders | Vehicle Foam | 0 | 291 | |
| other | Ocular hyperaemia | Eye disorders | Generic Azelaic Acid Foam | 1 | 306 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Azelaic Acid Foam | 0 | 306 |
| Total, all-cause mortality | Finacea (Azelaic Acid) Foam | 0 | 297 |
| Total, all-cause mortality | Vehicle Foam | 0 | 291 |
| Total, other adverse events | Generic Azelaic Acid Foam | 129 | 306 |
| Total, other adverse events | Finacea (Azelaic Acid) Foam | 128 | 297 |
| Total, other adverse events | Vehicle Foam | 125 | 291 |
| Total, serious adverse events | Generic Azelaic Acid Foam | 0 | 306 |
| Total, serious adverse events | Finacea (Azelaic Acid) Foam | 2 | 297 |
| Total, serious adverse events | Vehicle Foam | 1 | 291 |
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/NCT03287791
GET https://conductscience.org/api/trials/v1/NCT03287791/events?page=2