Trial Outcomes & Findings for DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT02070965)
NCT ID: NCT02070965
Last Updated: 2024-03-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Day 15
Results posted on
2024-03-07
Participant Flow
Participant milestones
| Measure |
DFD01 Spray Group 1
DFD01 Spray, bid, 28 days
DFD01 Spray
|
Comp01 Lotion
Comp01 Lotion, bid, 14 days
Comp01 Lotion
|
DFD01 Spray Group 2
DFD01 Spray, bid, 14 days
DFD01 Spray
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
25
|
|
Overall Study
COMPLETED
|
25
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
DFD01 Spray Group 1
DFD01 Spray, bid, 28 days
DFD01 Spray
|
Comp01 Lotion
Comp01 Lotion, bid, 14 days
Comp01 Lotion
|
DFD01 Spray Group 2
DFD01 Spray, bid, 14 days
DFD01 Spray
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Subject moved
|
1
|
0
|
0
|
Baseline Characteristics
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
DFD01 Spray Group 1
n=27 Participants
DFD01 Spray, bid, 28 days
DFD01 Spray
|
Comp01 Lotion
n=22 Participants
Comp01 Lotion, bid, 14 days
Comp01 Lotion
|
DFD01 Spray Group 2
n=25 Participants
DFD01 Spray, bid, 14 days
DFD01 Spray
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 11.55 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
53 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 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
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Percent Body Surface Area (BSA) involved
|
26.5 Percent BSA affected
STANDARD_DEVIATION 8.61 • n=5 Participants
|
26.8 Percent BSA affected
STANDARD_DEVIATION 6.32 • n=7 Participants
|
29.0 Percent BSA affected
STANDARD_DEVIATION 11.04 • n=5 Participants
|
27.4 Percent BSA affected
STANDARD_DEVIATION 8.90 • n=4 Participants
|
|
Investigator's Global Assessment (IGA)
IGA 3 (Moderate)
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Investigator's Global Assessment (IGA)
IGA 4 (Severe/Very Severe)
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Normal Adrenal Corticotropic Hormone (ACTH) test
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results.
Outcome measures
| Measure |
DFD01 Spray Group 1
n=24 Participants
DFD01 Spray, bid, 28 days
DFD01 Spray
|
Comp01 Lotion
n=20 Participants
Comp01 Lotion, bid, 14 days
Comp01 Lotion
|
DFD01 Spray Group 2
n=24 Participants
DFD01 Spray, bid, 14 days
DFD01 Spray
|
|---|---|---|---|
|
The Number of Subjects With HPA Axis Suppression
|
0 Participants
|
5 Participants
|
5 Participants
|
Adverse Events
DFD01 Spray Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Comp01 Lotion
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
DFD01 Spray Group 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DFD01 Spray Group 1
n=27 participants at risk
DFD01 Spray, bid, 28 days
DFD01 Spray
|
Comp01 Lotion
n=22 participants at risk
Comp01 Lotion, bid, 14 days
Comp01 Lotion
|
DFD01 Spray Group 2
n=25 participants at risk
DFD01 Spray, bid, 14 days
DFD01 Spray
|
|---|---|---|---|
|
Endocrine disorders
HPA Axis Suppression
|
0.00%
0/27
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
22.7%
5/22 • Number of events 5
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
20.0%
5/25 • Number of events 5
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
|
General disorders
Application Site Pruritus
|
7.4%
2/27 • Number of events 2
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
4.5%
1/22 • Number of events 1
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
4.0%
1/25 • Number of events 1
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
|
Nervous system disorders
Headache
|
0.00%
0/27
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
0.00%
0/22
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
8.0%
2/25 • Number of events 2
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60