Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

Rosacea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131636
• Other study ID #: 199201-004
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

• Greater than 3 inflammatory lesions on the face

• Current treatment with monoamine oxidase (MAO) inhibitors

• Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Related Conditions & MeSH terms

• Erythema
• Rosacea

Intervention

Drug:
• AGN-199201
AGN-199201 applied to the face once daily for 29 days.
• Vehicle to AGN-199201
Vehicle to AGN-199201 applied to the face once daily for 29 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales	The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.	Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary	Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale	The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.	Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary	Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)	Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).	Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary	Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9	The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.	Day 29 (Hours 3, 6, 9, and 12)
Secondary	Change From Baseline on the SA-RFR Questionnaire Item #4	The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).	Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary	Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale	The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.	Baseline, Day 1 (Hour 1)