Trial Outcomes & Findings for A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis (NCT NCT01947491)
NCT ID: NCT01947491
Last Updated: 2024-03-07
Results Overview
IGA of clear or almost clear
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
394 participants
Primary outcome timeframe
Day 15
Results posted on
2024-03-07
Participant Flow
Participant milestones
| Measure |
DFD01 Spray
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
174
|
87
|
90
|
43
|
|
Overall Study
COMPLETED
|
166
|
81
|
88
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
2
|
5
|
Reasons for withdrawal
| Measure |
DFD01 Spray
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Worsening of condition
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
2
|
Baseline Characteristics
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
Baseline characteristics by cohort
| Measure |
DFD01 Spray
n=174 Participants
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
n=87 Participants
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
n=90 Participants
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
n=43 Participants
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 14.12 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 12.67 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 13.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
174 participants
n=5 Participants
|
87 participants
n=7 Participants
|
90 participants
n=5 Participants
|
43 participants
n=4 Participants
|
394 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.
IGA of clear or almost clear
Outcome measures
| Measure |
DFD01 Spray
n=174 Participants
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
n=87 Participants
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
|---|---|---|---|---|
|
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
|
19.0 percentage of patients
Interval 13.1 to 24.8
|
2.3 percentage of patients
Interval 0.0 to 5.4
|
—
|
—
|
Adverse Events
DFD01 Spray
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Vehicle Spray
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Comp01 Lotion
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Vehicle Lotion
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFD01 Spray
n=173 participants at risk
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
n=87 participants at risk
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
n=90 participants at risk
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
n=43 participants at risk
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/87 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/90
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/173
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/87
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
1.1%
1/90 • Number of events 1
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
0.00%
0/43
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
Other adverse events
| Measure |
DFD01 Spray
n=173 participants at risk
DFD01 Spray twice daily for 28 days
DFD01 Spray
|
Vehicle Spray
n=87 participants at risk
Vehicle Spray twice daily for 28 days
Vehicle Spray
|
Comp01 Lotion
n=90 participants at risk
Comp01 Lotion twice daily for 14 days
Comp01 Lotion
|
Vehicle Lotion
n=43 participants at risk
Vehicle Lotion twice daily for 28 days
Vehicle Lotion
|
|---|---|---|---|---|
|
General disorders
Application Site Pain
|
7.5%
13/173 • Number of events 13
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
11.5%
10/87 • Number of events 10
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
14.4%
13/90 • Number of events 13
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
23.3%
10/43 • Number of events 10
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
|
General disorders
Application Site Pruritis
|
5.8%
10/173 • Number of events 10
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
10.3%
9/87 • Number of events 9
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
6.7%
6/90 • Number of events 6
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
32.6%
14/43 • Number of events 14
One subject in the betamethasone dipropionate 0.05% group had no post-baseline safety evaluations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60