Phase 3 N=440 Treatment

A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea

Erythema · Rosacea

Bottom Line

View on ClinicalTrials.gov: NCT02095158 ↗

Enrolled (actual)

440

Serious AEs

3.4%

Results posted

Sep 2016

Primary outcome: Primary: Percentage of Participants With Treatment-Related Adverse Events — 8.2 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Oxymetazoline HCL Cream 1.0% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Aug 2015

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.