Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01579084
Collaborator
(none)
64
1
10
2
31.9
Study Details
Study Description
Brief Summary
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
Study Design
Study Type:
Interventional
Actual Enrollment
:
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Jun 1, 2012
Actual Study Completion Date
:
Jun 1, 2012
Arms and Interventions
| 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.
|
| Other: 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.
|
| Other: 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.
|
| Other: 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
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 [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 [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 [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 [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
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01579084
Other Study ID Numbers:
- 199201-001
First Posted:
Apr 17, 2012
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 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/Group 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 for 5 days. | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. | 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 for 5 days. | 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 for 5 days. | 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 for 5 days. | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. |
| Period Title: Overall Study | ||||||||||
| STARTED | 8 | 8 | 8 | 8 | 8 | 8 | 4 | 4 | 4 | 4 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 | 8 | 4 | 4 | 4 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group 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 for 5 days. | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. | 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 for 5 days. | 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 for 5 days. | 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 for 5 days. | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. | Total of all reporting groups |
| Overall Participants | 8 | 8 | 8 | 8 | 8 | 8 | 4 | 4 | 4 | 4 | 64 |
| Age, Customized (Number) [Number] | |||||||||||
| < 45 years |
1
12.5%
|
1
12.5%
|
1
12.5%
|
4
50%
|
0
0%
|
1
12.5%
|
0
0%
|
1
25%
|
1
25%
|
0
0%
|
10
15.6%
|
| 45 to 65 years |
7
87.5%
|
6
75%
|
6
75%
|
4
50%
|
8
100%
|
7
87.5%
|
3
75%
|
3
75%
|
2
50%
|
4
100%
|
50
78.1%
|
| > 65 years |
0
0%
|
1
12.5%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
1
25%
|
0
0%
|
4
6.3%
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
5
62.5%
|
8
100%
|
6
75%
|
7
87.5%
|
5
62.5%
|
7
87.5%
|
2
50%
|
4
100%
|
2
50%
|
3
75%
|
49
76.6%
|
| Male |
3
37.5%
|
0
0%
|
2
25%
|
1
12.5%
|
3
37.5%
|
1
12.5%
|
2
50%
|
0
0%
|
2
50%
|
1
25%
|
15
23.4%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Formulation A | AGN-199201 Formulation B | AGN-199201 Formulation C | AGN-199201 Vehicle |
|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups. | AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups. | AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups. | AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups. |
| Measure Participants | 28 | 28 | 28 | 28 |
| Measure Facial Sides | 32 | 32 | 32 | 32 |
| Number [Percentage of responders] |
15.6
|
21.9
|
28.1
|
0.0
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Formulation A | AGN-199201 Formulation B | AGN-199201 Formulation C | AGN-199201 Vehicle |
|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups. | AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups. | AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups. | AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups. |
| Measure Participants | 28 | 28 | 28 | 28 |
| Measure Facial sides | 32 | 32 | 32 | 32 |
| Day 1-hour 6 |
34.4
|
34.4
|
40.6
|
0.0
|
| Day 5-hour 6 (Facial Sides n=32,31,31,32) |
15.6
|
6.5
|
6.5
|
6.3
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Formulation A | AGN-199201 Formulation B | AGN-199201 Formulation C | AGN-199201 Vehicle |
|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups. | AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups. | AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups. | AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups. |
| Measure Participants | 28 | 28 | 28 | 28 |
| Measure Facial sides | 32 | 32 | 32 | 32 |
| Day1-hour 6 |
31.3
|
46.9
|
56.3
|
3.1
|
| Day 5-hour 6 (Facial Sides n=32,31,31,32) |
34.4
|
41.9
|
58.1
|
28.1
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Formulation A | AGN-199201 Formulation B | AGN-199201 Formulation C | AGN-199201 Vehicle |
|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups. | AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups. | AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups. | AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups. |
| Measure Participants | 28 | 28 | 28 | 28 |
| Measure Facial sides | 32 | 31 | 31 | 32 |
| Number [Percentage of responders] |
6.3
|
6.5
|
6.5
|
3.1
|
Adverse Events
| Time Frame | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received. | |||||||||||||||||||
| Arm/Group Title | 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/Group 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 for 5 days. | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. | 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 for 5 days. | 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 for 5 days. | 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 for 5 days. | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| 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 | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| 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 | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| 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 | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/8 (37.5%) | 5/8 (62.5%) | 3/8 (37.5%) | 6/8 (75%) | 6/8 (75%) | 4/8 (50%) | 3/4 (75%) | 3/4 (75%) | 3/4 (75%) | 2/4 (50%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Eye pruritus | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Lip dry | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Nausea | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Application site anaesthesia | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site dryness | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site erosion | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site erythema | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site exfoliation | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site nodule | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||
| Application site pain | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 2/8 (25%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) | ||||||||||
| Application site papules | 1/8 (12.5%) | 3/8 (37.5%) | 0/8 (0%) | 2/8 (25%) | 2/8 (25%) | 0/8 (0%) | 2/4 (50%) | 1/4 (25%) | 2/4 (50%) | 0/4 (0%) | ||||||||||
| Application site paraesthesia | 1/8 (12.5%) | 2/8 (25%) | 2/8 (25%) | 2/8 (25%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site pruritus | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | ||||||||||
| Application site rash | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Application site warmth | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Immune system disorders | ||||||||||||||||||||
| Seasonal allergy | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Application site pustules | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 1/4 (25%) | 1/4 (25%) | 2/4 (50%) | 0/4 (0%) | ||||||||||
| Gastroenteritis viral | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Infected bites | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Vaginitis bacterial | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Muscle spasms | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Back Pain | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Dysgeusia | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Headache | 0/8 (0%) | 2/8 (25%) | 0/8 (0%) | 1/8 (12.5%) | 3/8 (37.5%) | 3/8 (37.5%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Migraine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Paraesthesia | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Somnolence | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Nasal dryness | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Oropharyngeal pain | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Sinus congestion | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Acne | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Dermatitis contact | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||
| Pruritus | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
| Skin tightness | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Therapeutic Area Head, |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01579084
Other Study ID Numbers:
- 199201-001
First Posted:
Apr 17, 2012
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019