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

Purpose

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

Condition	Intervention	Phase
Rosacea Erythema	Drug: AGN-199201 Formulation A Drug: AGN-199201 Formulation B Drug: AGN-199201 Formulation C Drug: AGN-199201 Vehicle	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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 [ Time Frame: Baseline, Day 1-hour 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Day 5-hour 6 ] [ Designated as safety issue: No ]
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:

Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA [ Time Frame: Baseline, Day 1-hour 6, Day 5-hour 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, Day1-hour 6, Day 5-hour 6 ] [ Designated as safety issue: No ]
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.


Enrollment:	64
Study Start Date:	April 2012
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AGN-199201 Formulation A and 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.	Drug: AGN-199201 Formulation A AGN-199201 Formulation A applied to the face as per protocol twice daily. Drug: AGN-199201 Formulation B AGN-199201 Formulation B applied to the face as per protocol twice daily.
Experimental: AGN-199201 Formulation B and 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.	Drug: AGN-199201 Formulation B AGN-199201 Formulation B applied to the face as per protocol twice daily. Drug: AGN-199201 Formulation C AGN-199201 Formulation C applied to the face as per protocol twice daily.
Experimental: AGN-199201 Formulation C and 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.	Drug: AGN-199201 Formulation A AGN-199201 Formulation A applied to the face as per protocol twice daily. Drug: AGN-199201 Formulation C AGN-199201 Formulation C applied to the face as per protocol twice daily.
AGN-199201 Formulation A and 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.	Drug: AGN-199201 Formulation A AGN-199201 Formulation A applied to the face as per protocol twice daily. Drug: AGN-199201 Vehicle AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
AGN-199201 Formulation B and 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.	Drug: AGN-199201 Formulation B AGN-199201 Formulation B applied to the face as per protocol twice daily. Drug: AGN-199201 Vehicle AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
AGN-199201 Formulation C and 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.	Drug: AGN-199201 Formulation C AGN-199201 Formulation C applied to the face as per protocol twice daily. Drug: AGN-199201 Vehicle AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Experimental: AGN-199201 Formulation A AGN-199201 Formulation A applied to both sides of the face twice daily.	Drug: AGN-199201 Formulation A AGN-199201 Formulation A applied to the face as per protocol twice daily.
Experimental: AGN-199201 Formulation B AGN-199201 Formulation B applied to both sides of the face twice daily.	Drug: AGN-199201 Formulation B AGN-199201 Formulation B applied to the face as per protocol twice daily.
Experimental: AGN-199201 Formulation C AGN-199201 Formulation C applied to both sides of the face twice daily.	Drug: AGN-199201 Formulation C AGN-199201 Formulation C applied to the face as per protocol twice daily.
Placebo Comparator: AGN-199201 Vehicle AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.	Drug: AGN-199201 Vehicle AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579084

Locations


United States, Texas

Austin, Texas, United States

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information

No publications provided


Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01579084 History of Changes
Other Study ID Numbers:	199201-001
Study First Received:	April 13, 2012
Results First Received:	September 12, 2013
Last Updated:	September 12, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015