Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
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| ClinicalTrials.gov Identifier: NCT01579084 |
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Recruitment Status :
Completed
First Posted : April 17, 2012
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
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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.
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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. |
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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.
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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. |
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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.
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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. |
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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.
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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. |
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Experimental: AGN-199201 Formulation A
AGN-199201 Formulation A applied to both sides of the face twice daily.
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Drug: AGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily. |
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Experimental: AGN-199201 Formulation B
AGN-199201 Formulation B applied to both sides of the face twice daily.
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Drug: AGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily. |
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Experimental: AGN-199201 Formulation C
AGN-199201 Formulation C applied to both sides of the face twice daily.
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Drug: AGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily. |
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Placebo Comparator: AGN-199201 Vehicle
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
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Drug: AGN-199201 Vehicle
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily. |
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 ]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 ]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 ]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 ]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.
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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
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
| United States, Texas | |
| Austin, Texas, United States | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
| 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 |