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

Phase 3

Completed

• Conditions: Erythema; Rosacea
• Interventions: Drug: Oxymetazoline HCL Cream 1.0%

• Registration Number: NCT02095158
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-24
• Study Start: 2014-04
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Results First Submitted: 2016-08-01
• Results First Submitted QC: 2016-08-01
• Results First Posted: 2016-09-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxymetazoline HCL Cream 1.0%	Oxymetazoline HCL Cream 1.0%	Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-Related Adverse Events	56 Weeks	An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.

Secondary Outcome Measures

Name	Time	Method
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	Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose	The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.