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

Primary Purpose

Rosacea, Erythema

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-199201 Formulation A
AGN-199201 Formulation B
AGN-199201 Formulation C
AGN-199201 Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Other

Other

Other

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AGN-199201 Formulation A and B

AGN-199201 Formulation B and C

AGN-199201 Formulation C and A

AGN-199201 Formulation A and Vehicle

AGN-199201 Formulation B and Vehicle

AGN-199201 Formulation C and Vehicle

AGN-199201 Formulation A

AGN-199201 Formulation B

AGN-199201 Formulation C

AGN-199201 Vehicle

Arm Description

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 applied to one side of the face and Formulation C applied to the other side of the face twice daily.

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 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 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 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 applied to both sides of the face twice daily.

AGN-199201 Formulation B applied to both sides of the face twice daily.

AGN-199201 Formulation C applied to both sides of the face twice daily.

AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.

Outcomes

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
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
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
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
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.

Full Information

First Posted
April 13, 2012
Last Updated
November 15, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01579084
Brief Title
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Erythema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-199201 Formulation A and B
Arm Type
Experimental
Arm Description
AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
Arm Title
AGN-199201 Formulation B and C
Arm Type
Experimental
Arm Description
AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
Arm Title
AGN-199201 Formulation C and A
Arm Type
Experimental
Arm Description
AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
Arm Title
AGN-199201 Formulation A and Vehicle
Arm Type
Other
Arm Description
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.
Arm Title
AGN-199201 Formulation B and Vehicle
Arm Type
Other
Arm Description
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.
Arm Title
AGN-199201 Formulation C and Vehicle
Arm Type
Other
Arm Description
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.
Arm Title
AGN-199201 Formulation A
Arm Type
Experimental
Arm Description
AGN-199201 Formulation A applied to both sides of the face twice daily.
Arm Title
AGN-199201 Formulation B
Arm Type
Experimental
Arm Description
AGN-199201 Formulation B applied to both sides of the face twice daily.
Arm Title
AGN-199201 Formulation C
Arm Type
Experimental
Arm Description
AGN-199201 Formulation C applied to both sides of the face twice daily.
Arm Title
AGN-199201 Vehicle
Arm Type
Placebo Comparator
Arm Description
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Formulation A
Intervention Description
AGN-199201 Formulation A applied to the face as per protocol twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Formulation B
Intervention Description
AGN-199201 Formulation B applied to the face as per protocol twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Formulation C
Intervention Description
AGN-199201 Formulation C applied to the face as per protocol twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Vehicle
Intervention Description
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Day 1-hour 6
Title
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
Description
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.
Time Frame
Baseline, Day 5-hour 6
Secondary Outcome Measure Information:
Title
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
Description
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.
Time Frame
Baseline, Day 1-hour 6, Day 5-hour 6
Title
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Description
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.
Time Frame
Baseline, Day1-hour 6, Day 5-hour 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Austin
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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

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