18 and older, any sex, with Rosacea. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12Primary· 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 elevat
Group
Value
95% CI
Generic Azelaic Acid Foam
-64.28
± 25.050
Finacea (Azelaic Acid) Foam
-65.15
± 26.419
Vehicle Foam
-57.84
± 30.626
Percentage of Participants With Treatment Success Based on IGE ScoreSecondary· 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).
Group
Value
95% CI
Generic Azelaic Acid Foam
39.7
Finacea (Azelaic Acid) Foam
48.3
Vehicle Foam
33.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Day 84.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Actavis Inc.
Last refreshed: 31 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03287791.