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

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ClinicalTrials.gov Identifier: NCT01579084
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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 :
  1. 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 ]
    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.

  2. Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579084


Locations
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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01579084     History of Changes
Other Study ID Numbers: 199201-001
First Posted: April 17, 2012    Key Record Dates
Results First Posted: November 15, 2013
Last Update Posted: November 15, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Rosacea
Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms