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

Phase 1

Completed

• Conditions: Rosacea; Erythema
• Interventions: Drug: AGN-199201 Formulation A; Drug: AGN-199201 Formulation B; Drug: AGN-199201 Formulation C; Drug: AGN-199201 Vehicle

• Registration Number: NCT01579084
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-09-12
• Results First Submitted QC: 2013-09-12
• Results First Posted: 2013-11-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• facial erythema associated with rosacea on both sides of the face

Exclusion Criteria

• Laser light-source or other energy based therapy in the last 6 months
• Excessive hair around the treatment area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-199201 Formulation A and B	AGN-199201 Formulation B	AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
AGN-199201 Formulation B and C	AGN-199201 Formulation B	AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
AGN-199201 Formulation B and C	AGN-199201 Formulation C	AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
AGN-199201 Formulation A and B	AGN-199201 Formulation A	AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
AGN-199201 Formulation B and Vehicle	AGN-199201 Vehicle	AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation C and A	AGN-199201 Formulation A	AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
AGN-199201 Formulation C and A	AGN-199201 Formulation C	AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
AGN-199201 Formulation A and Vehicle	AGN-199201 Formulation A	AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation A and Vehicle	AGN-199201 Vehicle	AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation B and Vehicle	AGN-199201 Formulation B	AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation C and Vehicle	AGN-199201 Formulation C	AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation C and Vehicle	AGN-199201 Vehicle	AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation A	AGN-199201 Formulation A	AGN-199201 Formulation A applied to both sides of the face twice daily.
AGN-199201 Formulation B	AGN-199201 Formulation B	AGN-199201 Formulation B applied to both sides of the face twice daily.
AGN-199201 Formulation C	AGN-199201 Formulation C	AGN-199201 Formulation C applied to both sides of the face twice daily.
AGN-199201 Vehicle	AGN-199201 Vehicle	AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.

Primary Outcome Measures

Name	Time	Method
Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1	Baseline, Day 1-hour 6	The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5	Baseline, Day 5-hour 6	The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA	Baseline, Day 1-hour 6, Day 5-hour 6	The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness.
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA	Baseline, Day1-hour 6, Day 5-hour 6	The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.