Trial Outcomes & Findings for Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis (NCT NCT01745133)
NCT ID: NCT01745133
Last Updated: 2016-11-17
Results Overview
Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear 1. = almost clear 2. = mild 3. = moderate 4. = severe
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
10 weeks
Results posted on
2016-11-17
Participant Flow
5 screen failure
Participant milestones
| Measure |
Vehicle 19
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
|
Calcipotriene 20
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
|
Calcipotriene + Clobetasol Propionate 20
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
19
|
|
Overall Study
COMPLETED
|
13
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Vehicle 19
n=19 Participants
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
|
Calcipotriene 20
n=20 Participants
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
|
Calcipotriene + Clobetasol Propionate 20
n=19 Participants
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
07 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPercentage of participants with clear or almost clear skin on the PGA scale. 0 = clear 1. = almost clear 2. = mild 3. = moderate 4. = severe
Outcome measures
| Measure |
Vehicle 68%
n=13 Participants
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
|
Calcipotriene 80%
n=16 Participants
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
|
Calcipotriene + Clobetasol Propionate 79%
n=15 Participants
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
|
|---|---|---|---|
|
Physician Global Assessement
|
68 percentage of patients
|
80 percentage of patients
|
79 percentage of patients
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Calcipotriene 80%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Calcipotriene + Clobetasol Propionate 79%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle
n=19 participants at risk
clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
|
Calcipotriene 80%
n=20 participants at risk
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x
calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
|
Calcipotriene + Clobetasol Propionate 79%
n=19 participants at risk
clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
right hand fracture
|
5.3%
1/19
|
0.00%
0/20
|
0.00%
0/19
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/19
|
5.0%
1/20
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
worsening of burning and itching
|
0.00%
0/19
|
0.00%
0/20
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/19
|
5.0%
1/20
|
0.00%
0/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place