Trial Outcomes & Findings for Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis (NCT NCT02749799)
NCT ID: NCT02749799
Last Updated: 2024-03-07
Results Overview
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
COMPLETED
PHASE4
45 participants
Change from Baseline to Day 14.
2024-03-07
Participant Flow
Participant milestones
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
n=45 Participants
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
|
Percent Body Surface Area Involved
|
11.9 Percentage of Body Surface Area
STANDARD_DEVIATION 10.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 14.Population: The ITT population included all randomized patients.
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
Outcome measures
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
n=45 Participants
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Change in Investigator's Global Assessment Grade
|
-0.8 units on a scale
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 14.Population: The ITT population included all patients randomized.
Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
Outcome measures
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
n=45 Participants
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Change in Percent Body Surface Area (BSA) Involved.
|
-1.3 percentage of BSA
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Change from Baseline to Day 14.Population: The ITT population included all subjects randomized.
DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.
Outcome measures
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
n=45 Participants
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Change in Dermatology Life Quality Index (DLQI)
|
-6.6 units on a scale
Standard Deviation 6.72
|
Adverse Events
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
Serious adverse events
| Measure |
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
n=45 participants at risk
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
DFD-01 (betamethasone dipropionate) Spray, 0.05%: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
|
|---|---|
|
Injury, poisoning and procedural complications
Hip Fracture due to accidental fall
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded from the time of informed consent up to the end of treatment (an average of 29 days).
AEs were systematically recorded at every visit by direct questioning and in between the visits by the use of patient diaries. The patients could also call up the site staff directly by phone and report AEs. The AEs were recorded from the time of ICF signing up to the day of last treatment (an average of 29 days). The AEs were followed up until resolution, or lost to follow up, or death of the patient, or until 30 days after the last treatment administration.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded from the time of informed consent up to the end of treatment (an average of 29 days).
AEs were systematically recorded at every visit by direct questioning and in between the visits by the use of patient diaries. The patients could also call up the site staff directly by phone and report AEs. The AEs were recorded from the time of ICF signing up to the day of last treatment (an average of 29 days). The AEs were followed up until resolution, or lost to follow up, or death of the patient, or until 30 days after the last treatment administration.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place