Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis (NCT NCT02932462)
NCT ID: NCT02932462
Last Updated: 2018-12-06
Results Overview
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
373 participants
Primary outcome timeframe
from baseline to study day 29
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
DSXS 1535
DSXS 1535 topical product
DSXS: topical product
|
Placebo
Vehicle
Placebo: topical product
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
189
|
|
Overall Study
COMPLETED
|
177
|
176
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
| Measure |
DSXS 1535
DSXS 1535 topical product
DSXS: topical product
|
Placebo
Vehicle
Placebo: topical product
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Protocol Violation
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
1
|
|
Overall Study
Progressive Disease
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
Baseline characteristics by cohort
| Measure |
DSXS 1535
n=183 Participants
DSXS 1535 topical product
DSXS: topical product
|
Placebo
n=189 Participants
Vehicle
Placebo: topical product
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 17.3 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
210 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
324 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
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Percent Scalp Affected
|
32.4 percent
STANDARD_DEVIATION 26.6 • n=5 Participants
|
33.5 percent
STANDARD_DEVIATION 25.3 • n=7 Participants
|
33.0 percent
STANDARD_DEVIATION 25.9 • n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
<= 3 Months
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=7 Participants
|
2 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
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 1 Year And <= 3 Years
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 3 Years And <= 5 Years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis
> 5 Years
|
116 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to study day 29Population: Patients with moderate and severe scalp psoriasis (primary analysis 1)
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Outcome measures
| Measure |
DSXS 1535
n=106 Participants
DSXS 1535 topical product
DSXS: topical product
|
Placebo
n=126 Participants
Vehicle
Placebo: topical product
|
|---|---|---|
|
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
|
41 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: from baseline to study day 29Population: Patients with mild to severe scalp psoriasis (primary analysis 2)
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Outcome measures
| Measure |
DSXS 1535
n=183 Participants
DSXS 1535 topical product
DSXS: topical product
|
Placebo
n=189 Participants
Vehicle
Placebo: topical product
|
|---|---|---|
|
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
|
51 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: from baseline to study day 29IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Outcome measures
| Measure |
DSXS 1535
n=77 Participants
DSXS 1535 topical product
DSXS: topical product
|
Placebo
n=63 Participants
Vehicle
Placebo: topical product
|
|---|---|---|
|
Clinical Success in Patients With Mild Scalp Psoriasis
|
10 Participants
|
7 Participants
|
Adverse Events
DSXS 1535
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DSXS 1535
n=180 participants at risk
DSXS 1535 topical product
DSXS: topical product
|
Placebo
n=189 participants at risk
Vehicle
Placebo: topical product
|
|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Eye disorders
Eye irritation
|
1.1%
2/180 • Number of events 2 • 9 months
|
2.6%
5/189 • Number of events 5 • 9 months
|
|
Eye disorders
Eye pain
|
0.00%
0/180 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Eye disorders
Eye pruritus
|
1.1%
2/180 • Number of events 2 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Eye disorders
Lacrimation increased
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Eye disorders
Ocular discomfort
|
2.2%
4/180 • Number of events 4 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Eye disorders
Ocular hyperaemia
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Eye disorders
Photophobia
|
0.56%
1/180 • Number of events 1 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/180 • Number of events 2 • 9 months
|
0.00%
0/189 • 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
3/180 • Number of events 3 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Flatulence
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
General disorders
Application site discomfort
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
General disorders
Application site dryness
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
General disorders
Application site pain
|
1.7%
3/180 • Number of events 3 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
General disorders
Application site pruritus
|
1.7%
3/180 • Number of events 3 • 9 months
|
2.1%
4/189 • Number of events 4 • 9 months
|
|
General disorders
Asthenia
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
General disorders
Pyrexia
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
General disorders
Xerosis
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/180 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Infections and infestations
Ear infection
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
3/180 • Number of events 3 • 9 months
|
2.6%
5/189 • Number of events 5 • 9 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Infections and infestations
Otitis media
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Infections and infestations
Sinusitis
|
1.1%
2/180 • Number of events 2 • 9 months
|
0.00%
0/189 • 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/180 • Number of events 2 • 9 months
|
0.00%
0/189 • 9 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/180 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.56%
1/180 • Number of events 1 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Nervous system disorders
Headache
|
3.9%
7/180 • Number of events 7 • 9 months
|
6.3%
12/189 • Number of events 14 • 9 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.1%
2/180 • Number of events 2 • 9 months
|
0.00%
0/189 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/180 • Number of events 2 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.56%
1/180 • Number of events 1 • 9 months
|
1.1%
2/189 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.56%
1/180 • Number of events 1 • 9 months
|
0.00%
0/189 • 9 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/180 • 9 months
|
0.53%
1/189 • Number of events 1 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place