Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
1 other identifier
interventional
64
1 country
1
Brief Summary
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
November 15, 2013
CompletedNovember 18, 2019
November 1, 2019
2 months
April 13, 2012
September 12, 2013
November 15, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, Day 1-hour 6
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.
Baseline, Day 5-hour 6
Secondary Outcomes (2)
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
Baseline, Day 1-hour 6, Day 5-hour 6
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Baseline, Day1-hour 6, Day 5-hour 6
Study Arms (10)
AGN-199201 Formulation A and B
EXPERIMENTALAGN-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
EXPERIMENTALAGN-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 and A
EXPERIMENTALAGN-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
OTHERAGN-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
OTHERAGN-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
OTHERAGN-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
EXPERIMENTALAGN-199201 Formulation A applied to both sides of the face twice daily.
AGN-199201 Formulation B
EXPERIMENTALAGN-199201 Formulation B applied to both sides of the face twice daily.
AGN-199201 Formulation C
EXPERIMENTALAGN-199201 Formulation C applied to both sides of the face twice daily.
AGN-199201 Vehicle
PLACEBO COMPARATORAGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
Interventions
AGN-199201 Formulation A applied to the face as per protocol twice daily.
AGN-199201 Formulation B applied to the face as per protocol twice daily.
AGN-199201 Formulation C applied to the face as per protocol twice daily.
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Eligibility Criteria
You may qualify if:
- facial erythema associated with rosacea on both sides of the face
You may not qualify if:
- Laser light-source or other energy based therapy in the last 6 months
- Excessive hair around the treatment area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Austin, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 17, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 18, 2019
Results First Posted
November 15, 2013
Record last verified: 2019-11