Trial Outcomes & Findings for Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis (NCT NCT02933866)
NCT ID: NCT02933866
Last Updated: 2018-12-06
Results Overview
Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
371 participants
Primary outcome timeframe
Day 29
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
DSXS Topical
applied once daily for 28 days
DSXS topical: topical treatment
|
Vehicle Topical
applied once daily for 28 days
Vehicle topical: topical treatment
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
185
|
|
Overall Study
COMPLETED
|
174
|
176
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Baseline characteristics by cohort
| Measure |
DSXS Topical
n=186 Participants
applied once daily for 28 days
DSXS topical: topical treatment
|
Vehicle Topical
n=184 Participants
applied once daily for 28 days
Vehicle topical: topical treatment
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
84 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
203 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
338 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
186 participants
n=5 Participants
|
184 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Percent Scalp Affected
|
33.7 percent
STANDARD_DEVIATION 26.0 • n=5 Participants
|
29.2 percent
STANDARD_DEVIATION 23.8 • n=7 Participants
|
31.4 percent
STANDARD_DEVIATION 25.0 • n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
<= 3 Months
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 3 Months And <= 6 Months
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 6 Months And <= 1 Year
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 1 Year And <= 3 Years
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 3 Years And <= 5 Years
|
19 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 5 Years
|
102 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
Outcome measures
| Measure |
DSXS Topical
n=186 Participants
applied once daily for 28 days
DSXS topical: topical treatment
|
Vehicle Topical
n=184 Participants
applied once daily for 28 days
Vehicle topical: topical treatment
|
|---|---|---|
|
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
|
49 Participants
|
41 Participants
|
Adverse Events
DSXS Topical
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Vehicle Topical
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DSXS Topical
n=183 participants at risk
applied once daily for 28 days
DSXS topical: topical treatment
|
Vehicle Topical
n=183 participants at risk
applied once daily for 28 days
Vehicle topical: topical treatment
|
|---|---|---|
|
General disorders
Application site dermatitis
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
General disorders
Application site dryness
|
1.1%
2/183 • Number of events 2 • 8 months
|
0.55%
1/183 • Number of events 2 • 8 months
|
|
General disorders
Application site exfoliation
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
General disorders
Application site hyperaesthesia
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
General disorders
Application site irritation
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
General disorders
Application site pain
|
1.1%
2/183 • Number of events 2 • 8 months
|
3.3%
6/183 • Number of events 6 • 8 months
|
|
General disorders
Application site paraesthesia
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 3 • 8 months
|
|
General disorders
Application site pruritus
|
1.6%
3/183 • Number of events 3 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
General disorders
Fatigue
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
General disorders
Malaise
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Infections and infestations
Influenza
|
1.1%
2/183 • Number of events 2 • 8 months
|
0.00%
0/183 • 8 months
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/183 • Number of events 2 • 8 months
|
1.1%
2/183 • Number of events 2 • 8 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Metabolism and nutrition disorders
Gout
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/183 • Number of events 2 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Nervous system disorders
Headache
|
3.8%
7/183 • Number of events 8 • 8 months
|
4.9%
9/183 • Number of events 11 • 8 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Vascular disorders
Hypertension
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Eye disorders
Eye discharge
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Eye disorders
Eye irritation
|
2.2%
4/183 • Number of events 4 • 8 months
|
6.0%
11/183 • Number of events 13 • 8 months
|
|
Eye disorders
Eye pain
|
0.00%
0/183 • 8 months
|
2.2%
4/183 • Number of events 4 • 8 months
|
|
Eye disorders
Ocular hyperaemia
|
1.1%
2/183 • Number of events 2 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Eye disorders
Ocular icterus
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Eye disorders
Photophobia
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Eye disorders
Vision blurred
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Eye disorders
Visual impairment
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/183 • Number of events 2 • 8 months
|
1.1%
2/183 • Number of events 2 • 8 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.55%
1/183 • Number of events 1 • 8 months
|
1.1%
2/183 • Number of events 2 • 8 months
|
|
Gastrointestinal disorders
Flatulence
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/183 • Number of events 2 • 8 months
|
1.1%
2/183 • Number of events 2 • 8 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/183 • 8 months
|
0.55%
1/183 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.55%
1/183 • Number of events 1 • 8 months
|
0.00%
0/183 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place