Trial Outcomes & Findings for Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea (NCT NCT01579084)
NCT ID: NCT01579084
Last Updated: 2019-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Baseline, Day 1-hour 6
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
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 for 5 days.
|
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 for 5 days.
|
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 for 5 days.
|
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 for 5 days.
|
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 for 5 days.
|
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 for 5 days.
|
AGN-199201 Formulation A
AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation B
AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation C
AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Vehicle
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
AGN-199201 Formulation A and B
n=8 Participants
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 and C
n=8 Participants
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 and A
n=8 Participants
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 and Vehicle
n=8 Participants
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 and Vehicle
n=8 Participants
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 and Vehicle
n=8 Participants
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
n=4 Participants
AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation B
n=4 Participants
AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation C
n=4 Participants
AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Vehicle
n=4 Participants
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 45 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Age, Customized
45 to 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Age, Customized
> 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1-hour 6Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Formulation A
n=32 Facial Sides
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
n=32 Facial Sides
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
n=32 Facial Sides
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
n=32 Facial Sides
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.
|
|---|---|---|---|---|
|
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
|
15.6 Percentage of responders
|
21.9 Percentage of responders
|
28.1 Percentage of responders
|
0.0 Percentage of responders
|
PRIMARY outcome
Timeframe: Baseline, Day 5-hour 6Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Formulation A
n=32 Facial sides
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
n=31 Facial sides
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
n=31 Facial sides
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
n=32 Facial sides
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.
|
|---|---|---|---|---|
|
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
|
6.3 Percentage of responders
|
6.5 Percentage of responders
|
6.5 Percentage of responders
|
3.1 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline, Day 1-hour 6, Day 5-hour 6Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Formulation A
n=32 Facial sides
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
n=32 Facial sides
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
n=32 Facial sides
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
n=32 Facial sides
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.
|
|---|---|---|---|---|
|
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
Day 5-hour 6 (Facial Sides n=32,31,31,32)
|
15.6 Percentage of responders
|
6.5 Percentage of responders
|
6.5 Percentage of responders
|
6.3 Percentage of responders
|
|
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
Day 1-hour 6
|
34.4 Percentage of responders
|
34.4 Percentage of responders
|
40.6 Percentage of responders
|
0.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline, Day1-hour 6, Day 5-hour 6Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Formulation A
n=32 Facial sides
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
n=32 Facial sides
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
n=32 Facial sides
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
n=32 Facial sides
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.
|
|---|---|---|---|---|
|
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Day1-hour 6
|
31.3 Percentage of responders
|
46.9 Percentage of responders
|
56.3 Percentage of responders
|
3.1 Percentage of responders
|
|
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Day 5-hour 6 (Facial Sides n=32,31,31,32)
|
34.4 Percentage of responders
|
41.9 Percentage of responders
|
58.1 Percentage of responders
|
28.1 Percentage of responders
|
Adverse Events
AGN-199201 Formulation A and B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-199201 Formulation B and C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AGN-199201 Formulation C and A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-199201 Formulation A and Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AGN-199201 Formulation B and Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AGN-199201 Formulation C and Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AGN-199201 Formulation A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-199201 Formulation B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-199201 Formulation C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-199201 Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGN-199201 Formulation A and B
n=8 participants at risk
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 and C
n=8 participants at risk
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 and A
n=8 participants at risk
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 and Vehicle
n=8 participants at risk
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 and Vehicle
n=8 participants at risk
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 and Vehicle
n=8 participants at risk
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
n=4 participants at risk
AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation B
n=4 participants at risk
AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Formulation C
n=4 participants at risk
AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
|
AGN-199201 Vehicle
n=4 participants at risk
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pruritus
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site anaesthesia
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site dryness
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site erosion
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site erythema
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site exfoliation
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site nodule
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site pain
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
50.0%
2/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site papules
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
37.5%
3/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
50.0%
2/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
50.0%
2/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site paraesthesia
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
50.0%
2/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site pruritus
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site rash
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
General disorders
Application site warmth
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Infections and infestations
Application site pustules
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
50.0%
2/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Infections and infestations
Infected bites
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
2/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
37.5%
3/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
37.5%
3/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
25.0%
1/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
12.5%
1/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/8
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
0.00%
0/4
Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER