Trial Outcomes & Findings for A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis (NCT NCT02445807)
NCT ID: NCT02445807
Last Updated: 2018-05-15
Results Overview
The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
265 participants
Primary outcome timeframe
Day 15 Visit
Results posted on
2018-05-15
Participant Flow
Participant milestones
| Measure |
DFD-06 Cream
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
89
|
|
Overall Study
COMPLETED
|
176
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
DFD-06 Cream
n=176 Participants
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 Participants
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
152 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
176 participants
n=93 Participants
|
89 participants
n=4 Participants
|
265 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 15 VisitThe primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Outcome measures
| Measure |
DFD-06 Cream
n=176 Participants
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 Participants
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
Efficacy (Percentage of Subjects With Treatment Success)
|
30.1 percentage of participants
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 15The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Outcome measures
| Measure |
DFD-06 Cream
n=176 Participants
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 Participants
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
The Percent Change in Body Surface Area of Psoriasis
|
-25.1 percentage change in body surface area
Standard Deviation 36.60
|
-7.4 percentage change in body surface area
Standard Deviation 20.28
|
SECONDARY outcome
Timeframe: At Day 8 VisitThe percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Outcome measures
| Measure |
DFD-06 Cream
n=176 Participants
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 Participants
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
The Percentage of Subjects With Treatment Success at the Day 8 Visit.
|
14.2 percentage of participants
|
1.6 percentage of participants
|
Adverse Events
DFD-06 Cream
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFD-06 Cream
n=176 participants at risk
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 participants at risk
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
Other adverse events
| Measure |
DFD-06 Cream
n=176 participants at risk
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
DFD06-Cream: Twice daily topical application for 14 days.
|
Vehicle Cream
n=89 participants at risk
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Vehicle Cream: Twice daily topical application for 14 days.
|
|---|---|---|
|
Cardiac disorders
Heart Valve Incompetence
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/176 • Number of events 2 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
General disorders
application site discolouration
|
2.3%
4/176 • Number of events 4 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
General disorders
Application Site Fissure
|
0.57%
1/176 • Number of events 1 • 6 Months
|
5.6%
5/89 • Number of events 5 • 6 Months
|
|
General disorders
Application Site Pain
|
6.8%
12/176 • Number of events 12 • 6 Months
|
12.4%
11/89 • Number of events 11 • 6 Months
|
|
General disorders
Application Site Pruritus
|
2.8%
5/176 • Number of events 5 • 6 Months
|
15.7%
14/89 • Number of events 14 • 6 Months
|
|
General disorders
Application site Rash
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
General disorders
Chest Pain
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Immune system disorders
Seasonal Allergy
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Infections and infestations
Nasopharyngitis
|
0.57%
1/176 • Number of events 1 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Investigations
Blood Pressure Increased
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Nervous system disorders
Headache
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.1%
2/176 • Number of events 2 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/176 • 6 Months
|
1.1%
1/89 • Number of events 1 • 6 Months
|
|
Surgical and medical procedures
Tooth Extraction
|
0.57%
1/176 • Number of events 1 • 6 Months
|
0.00%
0/89 • 6 Months
|
|
Vascular disorders
Hypertension
|
1.1%
2/176 • Number of events 2 • 6 Months
|
0.00%
0/89 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place