Trial Outcomes & Findings for A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305) (NCT NCT01882647)
NCT ID: NCT01882647
Last Updated: 2017-02-13
Results Overview
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
Day 15
Results posted on
2017-02-13
Participant Flow
Recruitment period: June 2013 to February 2014 The location of clinical sites included dermatology clinics and clinical research centers.
All subjects who met the entry criteria were randomized and enrolled into the study.
Participant milestones
| Measure |
Active Arm
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
112
|
|
Overall Study
COMPLETED
|
108
|
106
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Active Arm
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -305)
Baseline characteristics by cohort
| Measure |
Active Arm
n=110 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=112 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean
|
50.8 years
STANDARD_DEVIATION 14.49 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 15.15 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 14.79 • n=5 Participants
|
|
Gender
Female
|
50 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Gender
Male
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
Active Arm
n=110 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=112 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
The Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
|
44.5 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 15Population: Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.
A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Outcome measures
| Measure |
Active Arm
n=110 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=112 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Scaling
|
59.1 percentage of participants
|
9.8 percentage of participants
|
|
The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Erythema
|
43.6 percentage of participants
|
10.7 percentage of participants
|
|
The Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Plaque Elevation
|
43.6 percentage of participants
|
8.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Interim analysis of IGA. "Treatment success" and IGA as defined in the primary outcome measure.
Outcome measures
| Measure |
Active Arm
n=107 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=107 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Percentage of Subjects With IGA "Treatment Success" at Day 8
|
12.1 percentage of participants
|
2.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Interim analysis of clinical signs of psoriasis. "Treatment success" for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure.
Outcome measures
| Measure |
Active Arm
n=107 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=107 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
Scaling
|
36.4 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
Erythema
|
13.1 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8
Plaque Elevation
|
17.8 percentage of participants
|
3.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 15Population: Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).
Outcome measures
| Measure |
Active Arm
n=108 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=105 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Change From Baseline in Pruritus Score at Day 15
|
-5.6 units on a scale
Standard Deviation 3.65
|
-1.9 units on a scale
Standard Deviation 3.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15Population: Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.
The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.
Outcome measures
| Measure |
Active Arm
n=108 Participants
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=106 Participants
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15
|
-2.4 Change in %BSA
Standard Deviation 2.68
|
-0.3 Change in %BSA
Standard Deviation 1.12
|
Adverse Events
Active Arm
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Arm
n=110 participants at risk
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=112 participants at risk
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease with Acute Exacerbation
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
Other adverse events
| Measure |
Active Arm
n=110 participants at risk
Topical lotion, applied twice daily
000-0551 Lotion
|
Vehicle Arm
n=112 participants at risk
Topical lotion, applied twice daily
Vehicle Lotion
|
|---|---|---|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Gastrointestinal disorders
Food poisoning
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
General disorders
Application site atrophy
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
General disorders
Application site pain
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
General disorders
Application site telangiectasia
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
General disorders
Chest discomfort
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Infections and infestations
Otitis media acute
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Injury, poisoning and procedural complications
Wound
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Investigations
Intraocular pressure increased
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Nervous system disorders
Headache
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/110 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.89%
1/112 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
0.00%
0/112 • Adverse events (AEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all participants enrolled in the study who were dispensed the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all participants (N=222) were included in the safety population. Most AEs were mild in severity.
|
Additional Information
Clinical Research, Therapeutics Inc.
Therapeutics, Inc.
Phone: 585-571-1800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review thirty days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER