AGN-199201 for the Treatment of Erythema With Rosacea
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01735201
Collaborator
(none)
357
1
8
6
59.7
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.
Study Design
Study Type:
Interventional
Actual Enrollment
:
357 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AGN-199201 Dose A Once Daily AGN-199201 Dose A applied once daily to the face for 28 days. |
Drug: AGN-199201 Dose A
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
|
| Experimental: AGN-199201 Dose B Once Daily AGN-199201 Dose B applied once daily to the face for 28 days. |
Drug: AGN-199201 Dose B
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
|
| Experimental: AGN-199201 Dose C Once Daily AGN-199201 Dose C applied once daily to the face for 28 days. |
Drug: AGN-199201 Dose C
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
|
| Placebo Comparator: AGN-199201 Vehicle Once Daily AGN-199201 Vehicle applied once daily to the face for 28 days. |
Drug: AGN-199201 Vehicle
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
|
| Experimental: AGN-199201 Dose A Twice Daily AGN-199201 Dose A applied twice daily to the face for 28 days. |
Drug: AGN-199201 Dose A
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
|
| Experimental: AGN-199201 Dose B Twice Daily AGN-199201 Dose B applied twice daily to the face for 28 days. |
Drug: AGN-199201 Dose B
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
|
| Experimental: AGN-199201 Dose C Twice Daily AGN-199201 Dose C applied twice daily to the face for 28 days. |
Drug: AGN-199201 Dose C
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
|
| Placebo Comparator: AGN-199201 Vehicle Twice Daily AGN-199201 Vehicle applied twice daily to the face for 28 days. |
Drug: AGN-199201 Vehicle
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) [Baseline, Day 28-hours 2 to 12]
Percentage of participants 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 were assessed on Day 28 hours 2 to 12. 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 Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28 [Baseline, Day 28-hour 0.5]
Percentage of participants 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 were assessed at 0.5 hour post-dose on Day 28. 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 Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28 [Baseline, Day 28-hour 1]
Percentage of participants 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 were assessed at 1 hour post-dose on Day 28. 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Redness of the skin caused by rosacea
Exclusion Criteria:
-
≥3 inflammatory lesions
-
Laser light-source or other energy based therapy in the last 6 months
-
Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
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:
NCT01735201
Other Study ID Numbers:
- 199201-002
First Posted:
Nov 28, 2012
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations. |
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Period Title: Overall Study | ||||||||
| STARTED | 45 | 44 | 44 | 44 | 45 | 45 | 45 | 44 |
| COMPLETED | 42 | 43 | 44 | 42 | 44 | 40 | 42 | 42 |
| NOT COMPLETED | 3 | 1 | 0 | 2 | 1 | 5 | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. | Total of all reporting groups |
| Overall Participants | 45 | 44 | 44 | 44 | 45 | 45 | 45 | 44 | 356 |
| Age, Customized (Number) [Number] | |||||||||
| < 45 years |
14
31.1%
|
15
34.1%
|
10
22.7%
|
14
31.8%
|
16
35.6%
|
11
24.4%
|
16
35.6%
|
9
20.5%
|
105
29.5%
|
| 45-64 years |
30
66.7%
|
23
52.3%
|
28
63.6%
|
24
54.5%
|
26
57.8%
|
29
64.4%
|
27
60%
|
28
63.6%
|
215
60.4%
|
| >= 65 years |
1
2.2%
|
6
13.6%
|
6
13.6%
|
6
13.6%
|
3
6.7%
|
5
11.1%
|
2
4.4%
|
7
15.9%
|
36
10.1%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
35
77.8%
|
35
79.5%
|
33
75%
|
38
86.4%
|
41
91.1%
|
34
75.6%
|
36
80%
|
33
75%
|
285
80.1%
|
| Male |
10
22.2%
|
9
20.5%
|
11
25%
|
6
13.6%
|
4
8.9%
|
11
24.4%
|
9
20%
|
11
25%
|
71
19.9%
|
Outcome Measures
| Title | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) |
|---|---|
| Description | Percentage of participants 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 were assessed on Day 28 hours 2 to 12. 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 28-hours 2 to 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Measure Participants | 45 | 44 | 44 | 44 | 45 | 45 | 45 | 44 |
| Hour 2 |
13.3
29.6%
|
20.5
46.6%
|
22.7
51.6%
|
6.8
15.5%
|
8.9
19.8%
|
17.8
39.6%
|
15.6
34.7%
|
6.8
15.5%
|
| Hour 4 |
17.8
39.6%
|
31.8
72.3%
|
27.3
62%
|
4.5
10.2%
|
11.1
24.7%
|
20.0
44.4%
|
22.2
49.3%
|
6.8
15.5%
|
| Hour 6 |
17.8
39.6%
|
22.7
51.6%
|
13.6
30.9%
|
4.5
10.2%
|
11.1
24.7%
|
13.3
29.6%
|
24.4
54.2%
|
4.5
10.2%
|
| Hour 8 |
15.6
34.7%
|
20.5
46.6%
|
20.5
46.6%
|
4.5
10.2%
|
8.9
19.8%
|
20.0
44.4%
|
20.0
44.4%
|
2.3
5.2%
|
| Hour 10 |
17.8
39.6%
|
20.5
46.6%
|
13.6
30.9%
|
4.5
10.2%
|
13.3
29.6%
|
15.6
34.7%
|
26.7
59.3%
|
2.3
5.2%
|
| Hour 12 |
13.3
29.6%
|
13.6
30.9%
|
13.6
30.9%
|
2.3
5.2%
|
13.3
29.6%
|
11.1
24.7%
|
15.6
34.7%
|
4.5
10.2%
|
| Title | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28 |
|---|---|
| Description | Percentage of participants 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 were assessed at 0.5 hour post-dose on Day 28. 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 28-hour 0.5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Measure Participants | 45 | 44 | 44 | 44 | 45 | 45 | 45 | 44 |
| Number [Percentage of participants] |
6.7
14.9%
|
11.4
25.9%
|
6.8
15.5%
|
4.5
10.2%
|
6.7
14.9%
|
6.7
14.9%
|
6.7
14.9%
|
2.3
5.2%
|
| Title | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28 |
|---|---|
| Description | Percentage of participants 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 were assessed at 1 hour post-dose on Day 28. 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 28-hour 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. |
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Measure Participants | 45 | 44 | 44 | 44 | 45 | 45 | 45 | 44 |
| Number [Percentage of participants] |
11.1
24.7%
|
13.6
30.9%
|
18.2
41.4%
|
2.3
5.2%
|
6.7
14.9%
|
11.1
24.7%
|
8.9
19.8%
|
2.3
5.2%
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily | ||||||||
| Arm/Group Description | AGN-199201 Dose A applied once daily to the face for 28 days. | AGN-199201 Dose B applied once daily to the face for 28 days. | AGN-199201 Dose C applied once daily to the face for 28 days. | AGN-199201 Vehicle applied once daily to the face for 28 days. | AGN-199201 Dose A applied twice daily to the face for 28 days. | AGN-199201 Dose B applied twice daily to the face for 28 days. | AGN-199201 Dose C applied twice daily to the face for 28 days. | AGN-199201 Vehicle applied twice daily to the face for 28 days. | ||||||||
All Cause Mortality |
||||||||||||||||
| AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily | |||||||||
| 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) | ||||||||
Serious Adverse Events |
||||||||||||||||
| AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily | |||||||||
| 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 | 0/45 (0%) | 1/44 (2.3%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 1/45 (2.2%) | 0/45 (0%) | 0/44 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Cardiac failure congestive | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Chondrocalcinosis pyrophosphate | 0/45 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||||
| Rotator cuff syndrome | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Cerebrovascular accident | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) | 0/45 (0%) | 1/45 (2.2%) | 0/45 (0%) | 0/44 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hypertension | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| AGN-199201 Dose A Once Daily | AGN-199201 Dose B Once Daily | AGN-199201 Dose C Once Daily | AGN-199201 Vehicle Once Daily | AGN-199201 Dose A Twice Daily | AGN-199201 Dose B Twice Daily | AGN-199201 Dose C Twice Daily | AGN-199201 Vehicle Twice Daily | |||||||||
| 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 | 5/45 (11.1%) | 5/44 (11.4%) | 1/44 (2.3%) | 1/44 (2.3%) | 2/45 (4.4%) | 6/45 (13.3%) | 7/45 (15.6%) | 6/44 (13.6%) | ||||||||
| General disorders | ||||||||||||||||
| Application site dermatitis | 0/45 (0%) | 3/44 (6.8%) | 0/44 (0%) | 0/44 (0%) | 1/45 (2.2%) | 3/45 (6.7%) | 2/45 (4.4%) | 0/44 (0%) | ||||||||
| Application site acne | 1/45 (2.2%) | 1/44 (2.3%) | 1/44 (2.3%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 1/45 (2.2%) | 3/44 (6.8%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Headache | 4/45 (8.9%) | 1/44 (2.3%) | 0/44 (0%) | 1/44 (2.3%) | 1/45 (2.2%) | 3/45 (6.7%) | 4/45 (8.9%) | 3/44 (6.8%) | ||||||||
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:
NCT01735201
Other Study ID Numbers:
- 199201-002
First Posted:
Nov 28, 2012
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019