Phase 3
Completed N=440
A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
Erythema · Rosacea
Source: ClinicalTrials.gov NCT02095158 ↗
Enrolled (actual)
440
Serious AEs
3.4%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Treatment-Related Adverse Events — 8.2 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Related Adverse Events |
8.2 | — |
| SECONDARY Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales |
11.6; 17.8; 1.2; 19.5; 23.0; 6.1 | — |
Eligibility Criteria
Inclusion Criteria
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Data sourced from ClinicalTrials.gov (NCT02095158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.