Trial Outcomes & Findings for DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT02131324)
NCT ID: NCT02131324
Last Updated: 2018-05-18
Results Overview
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day 15
Results posted on
2018-05-18
Participant Flow
Washout was needed at Screening Visit if prohibited therapies were in use. The screening adrenocorticotropic hormone (ACTH) stimulation test was conducted at least 14 days and no more than 28 days prior to the Baseline Visit.
Participant milestones
| Measure |
Comp01
applied twice a day for 15 days
Comp01
|
DFD06 Cream
applied twice a day for 15 days
DFD06 Cream
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
Analyzed
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Comp01
applied twice a day for 15 days
Comp01
|
DFD06 Cream
applied twice a day for 15 days
DFD06 Cream
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Two subjects dropped out of the study in each arm.
Baseline characteristics by cohort
| Measure |
DFD06
n=24 Participants
DFD06 Active
|
Comp01
n=22 Participants
Comp01 Comparator
|
Total
n=46 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
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Body Surface Area (BSA) affected by psoriasis
|
26.5 cm^2
STANDARD_DEVIATION 8.6 • n=5 Participants • Two subjects dropped out of the study in each arm.
|
27.0 cm^2
STANDARD_DEVIATION 8.3 • n=7 Participants • Two subjects dropped out of the study in each arm.
|
26.8 cm^2
STANDARD_DEVIATION 8.4 • n=5 Participants • Two subjects dropped out of the study in each arm.
|
PRIMARY outcome
Timeframe: Day 15Population: All summaries and analyses were performed on the safety population. All subjects who received at least one confirmed dose of study product and provided any post-baseline safety information were included in the safety population. No imputation was made for missing safety data.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Outcome measures
| Measure |
Clobetasol Propionate Cream, 0.05%
n=22 Participants
applied twice a day for 15 days
Clobetasol Propionate Cream, 0.05%
|
DFD06 Cream
n=24 Participants
applied twice a day for 15 days
DFD06 Cream
|
|---|---|---|
|
The Percentage of Subjects With HPA Axis Suppression.
|
36.4 percentage of participants
|
12.5 percentage of participants
|
Adverse Events
Clobetasol Propionate Cream, 0.05%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
DFD06 Cream
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clobetasol Propionate Cream, 0.05%
n=22 participants at risk
applied twice a day for 15 days
Clobetasol Propionate Cream 0.05%
|
DFD06 Cream
n=24 participants at risk
applied twice a day for 15 days
DFD06 Cream
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury/Stab Wound
|
0.00%
0/22
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Clobetasol Propionate Cream, 0.05%
n=22 participants at risk
applied twice a day for 15 days
Clobetasol Propionate Cream 0.05%
|
DFD06 Cream
n=24 participants at risk
applied twice a day for 15 days
DFD06 Cream
|
|---|---|---|
|
Endocrine disorders
HPA axis suppression
|
36.4%
8/22 • Number of events 8
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Application site pain
|
9.1%
2/22 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Application site pruritus
|
4.5%
1/22 • Number of events 1
|
0.00%
0/24
|
|
Investigations
Dehydroepiandrosterone sulfate dicreased
|
27.3%
6/22 • Number of events 6
|
8.3%
2/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60