Trial Outcomes & Findings for Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis (NCT NCT04091087)
NCT ID: NCT04091087
Last Updated: 2022-05-02
Results Overview
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
Vehicle Ointment
Participants applied vehicle ointment topically twice a day (BID) to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
Participants applied crisaborole ointment 2 percent (%) topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Treated
|
32
|
33
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Vehicle Ointment
Participants applied vehicle ointment topically twice a day (BID) to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
Participants applied crisaborole ointment 2 percent (%) topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Baseline characteristics by cohort
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 Years
STANDARD_DEVIATION 9.81 • n=93 Participants
|
66.0 Years
STANDARD_DEVIATION 8.64 • n=4 Participants
|
67.4 Years
STANDARD_DEVIATION 9.28 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.
Outcome measures
| Measure |
Vehicle Ointment
n=26 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=30 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment
|
-18.07 Percent change
Standard Error 5.47
|
-32.44 Percent change
Standard Error 5.09
|
SECONDARY outcome
Timeframe: Week 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline.
Outcome measures
| Measure |
Vehicle Ointment
n=26 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=30 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment
|
0 Percentage of participants
|
3.33 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 5 and 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Outcome measures
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 1
|
3.13 Percentage of participants
|
12.12 Percentage of participants
|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 2
|
15.63 Percentage of participants
|
15.15 Percentage of participants
|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 3
|
12.50 Percentage of participants
|
12.12 Percentage of participants
|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 4
|
12.50 Percentage of participants
|
12.12 Percentage of participants
|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 5
|
6.25 Percentage of participants
|
15.15 Percentage of participants
|
|
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 6
|
0 Percentage of participants
|
18.18 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner.
Outcome measures
| Measure |
Vehicle Ointment
n=26 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=30 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment
|
11.54 Percentage of participants
|
16.67 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 5 and 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Outcome measures
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 1
|
43.75 Percentage of participants
|
51.52 Percentage of participants
|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 2
|
37.50 Percentage of participants
|
54.55 Percentage of participants
|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 3
|
43.75 Percentage of participants
|
45.45 Percentage of participants
|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 4
|
43.75 Percentage of participants
|
45.45 Percentage of participants
|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 5
|
25.00 Percentage of participants
|
45.45 Percentage of participants
|
|
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 6
|
21.88 Percentage of participants
|
51.52 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5 and 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "number analyzed" signifies participants evaluable for the specified rows.
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Outcome measures
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 1
|
-20.35 Percent change
Standard Error 9.55
|
-16.48 Percent change
Standard Error 9.52
|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 2
|
-35.94 Percent change
Standard Error 8.14
|
-40.41 Percent change
Standard Error 8.26
|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 3
|
-34.86 Percent change
Standard Error 10.26
|
-25.05 Percent change
Standard Error 9.85
|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 4
|
-39.38 Percent change
Standard Error 11.14
|
-4.64 Percent change
Standard Error 11.12
|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 5
|
-27.23 Percent change
Standard Error 10.41
|
-28.89 Percent change
Standard Error 10.18
|
|
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 6
|
-10.29 Percent change
Standard Error 8.60
|
-52.48 Percent change
Standard Error 8.35
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner.
Outcome measures
| Measure |
Vehicle Ointment
n=26 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=30 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment
|
-10.72 Percent change
Standard Error 7.06
|
-3.80 Percent change
Standard Error 6.57
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5 and 6Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "number analyzed" signifies participants evaluable for the specified rows.
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Outcome measures
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 1
|
10.28 Percent change
Standard Error 14.73
|
-19.67 Percent change
Standard Error 14.98
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 2
|
-13.21 Percent change
Standard Error 13.07
|
-27.59 Percent change
Standard Error 13.50
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 3
|
-31.58 Percent change
Standard Error 10.85
|
-41.52 Percent change
Standard Error 10.44
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 4
|
-2.34 Percent change
Standard Error 15.80
|
-18.35 Percent change
Standard Error 15.93
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 5
|
-6.05 Percent change
Standard Error 13.87
|
-19.06 Percent change
Standard Error 13.91
|
|
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 6
|
18.67 Percent change
Standard Error 21.26
|
-34.34 Percent change
Standard Error 21.23
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs.
Outcome measures
| Measure |
Vehicle Ointment
n=32 Participants
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 Participants
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
14 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
4 Participants
|
1 Participants
|
Adverse Events
Vehicle Ointment
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Crisaborole 2% Ointment
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Ointment
n=32 participants at risk
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 participants at risk
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Cystitis
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
Other adverse events
| Measure |
Vehicle Ointment
n=32 participants at risk
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
Crisaborole 2% Ointment
n=33 participants at risk
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Fatigue
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Injection site erythema
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Injection site pruritus
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Oedema
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Tinea pedis
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
6.1%
2/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Nervous system disorders
Burning sensation
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
6.1%
2/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Nervous system disorders
Migraine
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
6.1%
2/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
6.1%
2/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
9.1%
3/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.1%
1/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
0.00%
0/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
|
Vascular disorders
Hot flush
|
0.00%
0/32 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
3.0%
1/33 • Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER